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Efficacy of the Use of Real-time Continuous Glucose Monitoring on Glycemic Control in Patients With Type 2 Diabetes and Stage 3 and 4 Chronic Kidney Disease.
NCT07668219
Not yet recruiting
Conditions Type 2 Diabetes, Kidney Disease, CGM, Ti...
Phase NA
Enrollment 30
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-15
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

* Rationale: Glucose control in patients with kidney disease is challenging, as traditional metrics can be unreliable and there is a high risk of hypoglycemia (low blood sugar). Although RT-CGM has shown benefits in other groups, its efficacy in patients with advanced kidney damage needs to be validated to improve their quality of life and prevent disease progression. * Main objective: To determine whether the use of RT-CGM is more effective than usual care (capillary blood glucose monitoring with a glucometer) in maintaining patients within an optimal glucose range (70-180 mg/dL) over a three-month period. * Study population: We plan to include 30 patients over 18 years of age with type 2 diabetes and chronic kidney disease (with a glomerular filtration rate less than 60 ml/min), who use insulin and are not on renal replacement therapy such as dialysis. * Methodology: The study is a randomized clinical trial consisting of two phases: 1. Selection period (15 days): Blinded monitoring is performed to obtain baseline data. 2. Treatment period (90 days): Patients are divided into two groups: the intervention group, which will use the CGM-RT with alarms configured for high and low levels, and the control group, which will continue with traditional fingerstick monitoring. * Metrics to be evaluated: In addition to time in range, researchers will analyze episodes of hypoglycemia and hyperglycemia, glycemic variability, glycated hemoglobin (HbA1c) levels, and device accuracy. * Ethical and logistical considerations: The study complies with international and national regulations, guaranteeing the confidentiality and autonomy of the participants. The project has a 24-month timeline and a detailed budget to cover medical personnel, monitoring sensors (Sinocare i3), and laboratory tests.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Device: Real time continuos glucose monitoring — Intervention group (users of real-time continuous glucose monitoring). Participants in the intervention group will be instructed on the use of real-time continuous glucose monitoring. This training will be provided by nursing staff and will include instruction on device use, alarm management, and recommendations for responding to hypoglycemic episodes reported by the device. Alarms will be configured as follows: High Glucose Alert ≥240 mg/dL and Low Glucose Alert ≤70 mg/dL. Data uploaded to the platform by the device will be reviewed monthly by a physician trained in diabetes management, who will make appropriate adjustments to therapy if participants experience hypoglycemic episodes (\<54 mg/dL and \<70 mg/dL) or recurrent hyperglycemic episodes (\>180 mg/dL), according to basal and prandial insulin titration recommendations. This group will be instructed to confirm readings below 70 mg/dL and above 240 mg/dL with capillary blood glucose monitoring to evaluate the device's accuracy withi
  • Device: self blood glucose monitoring — Control group: Continuous glucose monitoring will be installed, blinded to measure baseline glycemic control metrics and at the end of the study. Patients assigned to the control group will receive routine nursing education on glucometer use, frequency of capillary blood glucose monitoring, and recommendations for managing hypoglycemic episodes. Capillary glucose data will be reviewed monthly by a physician trained in diabetes management, who will make appropriate adjustments to therapy if subjects experience hypoglycemic events (\<54 mg/dL and \<70 mg/dL) or recurrent hyperglycemic events (\>180 mg/dL), according to basal and prandial insulin titration recommendations.

Primary Outcomes

  • Time in range (TIR) (12 weeks)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2026-11
Completion: 2027-05-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Hospital Universitario San Ignacio
Contact Information
Study Contact:
Ana M Gómez - Medina, Endocrinologyst
+57 601 5946161
agomez@husi.org.co
Diana Cristina Henao, MD
+57 601 5946161
dchenao@husi.org.co
Interventions
  • Device: Real time continuos glucose monitoring — Intervention group (users of real-time continuous glucose monitoring). Participants in the intervention group will be instructed on the use of real-time continuous glucose monitoring. This training will be provided by nursing staff and will include instruction on device use, alarm management, and recommendations for responding to hypoglycemic episodes reported by the device. Alarms will be configured as follows: High Glucose Alert ≥240 mg/dL and Low Glucose Alert ≤70 mg/dL. Data uploaded to the platform by the device will be reviewed monthly by a physician trained in diabetes management, who will make appropriate adjustments to therapy if participants experience hypoglycemic episodes (\<54 mg/dL and \<70 mg/dL) or recurrent hyperglycemic episodes (\>180 mg/dL), according to basal and prandial insulin titration recommendations. This group will be instructed to confirm readings below 70 mg/dL and above 240 mg/dL with capillary blood glucose monitoring to evaluate the device's accuracy withi
  • Device: self blood glucose monitoring — Control group: Continuous glucose monitoring will be installed, blinded to measure baseline glycemic control metrics and at the end of the study. Patients assigned to the control group will receive routine nursing education on glucometer use, frequency of capillary blood glucose monitoring, and recommendations for managing hypoglycemic episodes. Capillary glucose data will be reviewed monthly by a physician trained in diabetes management, who will make appropriate adjustments to therapy if subjects experience hypoglycemic events (\<54 mg/dL and \<70 mg/dL) or recurrent hyperglycemic events (\>180 mg/dL), according to basal and prandial insulin titration recommendations.
Study Locations (1 sites)
Hospital Universitario San Ignacio, Bogotá, Cundinamarca 111021 Colombia
Eligibility Criteria
4.2.1 Inclusion Criteria * Age over 18 years * Chronic kidney disease defined as a glomerular filtration rate (GFR) of less than 60 ml/min/1.73 m², in at least two measurements within the six months prior to inclusion. * Treatment with basal insulin, basal-bolus regimen, or co-formulation with or without oral antidiabetic agents, with or without a GLP-1 analogue, with stable treatment for the last 3 months. 4.2.2 Exclusion Criteria * Type 1 diabetes. * Severe cognitive impairment or dysfunction that prevents device management. * Chronic kidney disease on renal replacement therapy (peritoneal dialysis or hemodialysis). * Patients with a history of kidney transplantation.
Food Effect, Efficacy and Safety of MKP10241 in Healthy and Obese Adult Participants, With and Without Diabetes
NCT07098663
Recruiting
Conditions Type 2 Diabetes Mellitus (T2DM), Food Ef...
Phase PHASE2
Enrollment 68
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-09-15
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Study Details Design, interventions, and primary outcomes

About This Study

The goal of this intervention study is to evaluate the safety, tolerability and pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of MKP10241 in obese participants with and without T2DM in 3 parts. The main parameters it aims to answers are : 1. Does food effects the pharmacokinetic parameters following a single dose of MKP10241 in healthy participants? 2. Will multiple ascending doses of MKP10241 in obese participants with or without T2DM characterize changes in the plasma pharmacokinetic profile and pharmacodynamic effects? 3. What treatment emergent adverse events or discontinuation is experienced following single and multiple ascending doses of MKP10241 in healthy and obese participants with or without T2DM? This study will be compared against a placebo which is matched in appearance to MKP10241 at dosage strengths. Participants will: 1. Part 1: Take MKP10241 400 mg or Placebo on Day 1 and Day 8. Part 2: Take MKP10241 200 mg, 300 mg and 400 mg or Placebo daily from Day 1 to Day 28 Part 3: Take MKP10241 300 mg and 400 mg or Placebo daily from Day 1 to Day 28 2. Visit the clinical research unit for dose administration, admission or follow up. 3. Will be monitored by the Safety Monitoring Committee.

Design

Study type: Interventional Phases: Phase2 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: MKP10241 — Oral liquid suspension of unit dose strength 6.6 mg/mL
  • Drug: Placebo — Oral liquid suspension matched in appearance to MKP10241 at dosage strengths

Primary Outcomes

  • Part 1 - Food effect of single dose of MKP10241 on Maximum concentration of drug (Cmax) (18 days)
  • Part 1 - Food effect of single dose of MKP10241 on Apparent total clearance of drug (CL/F) (18 days)
  • Part 1 - Food effect of single dose of MKP10241 on Time to maximum concentration (Tmax) (18 days)
  • Part 1 - Food effect of single dose of MKP10241 on elimination half life (t1/2 ) (18 days)
  • Part 1 - Food effect of single dose of MKP10241 on lag time (Tlag) (18 days)
  • Part 1 - Food effect of single dose of MKP10241 on Apparent Volume of distribution of drug (V/F) (18 days)
  • Part 1 - Food effect of single dose of MKP10241 on Area under the curve from time 0 to 24hrs - AUC (0-24h) (18 days)
  • Part 1 - Food effect of single dose of MKP10241 on AUC(0-last) (18 days)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2025-08-12
Completion: 2026-04-17
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 68 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Mankind Pharma Limited
Collaborators: Emerald Clinical Inc.
Principal Investigators:
  • Stephen Hall, MBBS, FRACP (PRINCIPAL_INVESTIGATOR) - Veritus Research
Contact Information
Study Contact:
Mohammad M Ahsan, B. Pharm, M.Sc
+91 124 2873900
muneeb.ahsan@mankindpharma.com
Santosh Kumar Rai, MSc, PhD
+91 124 2873900
santosh.rai@mankindpharma.com
Interventions
  • Drug: MKP10241 — Oral liquid suspension of unit dose strength 6.6 mg/mL
  • Drug: Placebo — Oral liquid suspension matched in appearance to MKP10241 at dosage strengths
Study Locations (1 sites)
Veritus Research, Bayswater, Victoria 3153 Australia
Eligibility Criteria
Inclusion criteria * Male or female participants between 18 to 60 years of age * Considered healthy by the Investigator. Part 1: BMI of 18 to 30 kg/m2, and weight being not less than 50 kg. Part 2/3: BMI of ≥32 kg/m2 * Part 1/2: Fasting plasma glucose (FPG) between 3.9 mmol/L and 6.1 mmol/L. Part 3: FPG greater than or equal to 6.94 mmol/L and less than or equal to 14.43 mmol/L * A nonsmoker/social smoker, defined as not having smoked more than 5 cigarettes or equivalent per day in the 3 months prior to Screening. * Able to abstain from the consumption of alcohol and any alcohol-containing products from 48 hours before dosing to the End of Study Visit. * Female participants must be of nonchildbearing potential or, if of childbearing potential, must agree to use 1 form of highly effective contraceptive method, plus an additional barrier method of contraception between signing consent * Male participants who are sexually active must use a condom from Screening until at least 90 days after the last dose of study intervention (or be surgically sterile. Female partners of childbearing potential must use a highly effective method of contraception. * Capable of giving signed Informed Consent * Willing and able to adhere to study restrictions and to be confined at the CRU. * Part 3: Participants with an established diagnosis of type 2 diabetes mellitus * Part 3: Participants; type 2 diabetes mellitus must be managed by diet and exercise alone or by stable dose of metformin (for ≥2 months); the use of other antidiabetic therapies is prohibited Exclusion criteria * Clinically significant haematological findings at Screening. * Hepatic impairment including aspartate aminotransferase (AST), alanine transaminase (ALT), or alkaline phosphatase ≥1.5 times upper limit of normal (ULN), total bilirubin ≥2.0 times ULN, albumin ≤3.0 g/L, serum amylase or lipase ≥1.5 times ULN at Screening. * Renal impairment, such as creatinine ≥ULN, estimated glomerular filtration rate (eGFR) of ≤80 mL/minute/1.73m2 in adults, as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula * Positive polymerase chain reaction (PCR) test for severe-acute-respiratory-syndrome-related coronavirus (SARS-CoV-2) * A history of non-febrile seizures. * Positive pregnancy test result at Screening or on admission to the CRU, * Any major surgery within 60 days prior to Screening, or planned major surgery during the study. * Any history of malignant disease excluding surgically resected skin and in-situ cervical squamous cell or basal cell carcinoma. * Suspected hypersensitivity to MKP10241 and any components of MKP10241 liquid suspension * Any other condition which makes the participant unsuitable for study participation as judged by the Investigator or designee. * Participant has any history or evidence of any clinically significant disease * Prior or planned (during study period) bariatric surgery (e.g. gastric bands, gastroplasty Roux-e-Y gastric bypass) or ileal resection. * Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-V) substance use disorders and alcohol abuse within 12 months prior to Screening and/or positive alcohol breath test at Screening or admission. * Positive result for drugs of abuse at Screening or admission. * Use of live attenuated vaccines within 14 days prior to dosing * The use of medications (other than paracetamol), including hormonal contraceptives * Receipt of any other investigational medicinal product within one month or five half-lives (whichever is longer) prior to dosing. * Clinically significant ECG findings: QTcF value ≥450 ms for males or ≥470 ms for females at Screening or Day -1 * Participants with a mean systolic blood pressure \>140 mmHg, mean diastolic blood pressure \>90 mmHg at Screening. * Positive blood screen for human immunodeficiency virus antibody (HIV), hepatitis B surface antigen (HBsAg), syphilis, hepatitis C virus (HCV). * Change in body weight of ≥ 10% within 3 months prior to the Screening visit. * Donation or blood collection of more than 1 unit (approximate 450 mL) of blood (or blood products, plasma) or acute loss of blood during the 30 days prior to Screening. * Part 3: Type 1 diabetes mellitus, maturity-onset diabetes of the young, or other forms of diabetes.
Biomarkers as Predictors of Chronic Heart Failure in Patients With Type 2 Diabetes
NCT04941794
Recruiting
Conditions Type 2 Diabetes, Chronic Heart Failure
Phase Not Applicable
Enrollment 500
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-15
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

A cohort study on patients with type 2 diabetes to investigate possible biomarkers as predictors of chronic heart failure.

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Primary Outcomes

  • Chronic Heart Failure (During 5 year follow up)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2021-07-01
Completion: 2027-07
Eligibility
Age: 50 Years
Sex: ALL
Volunteers: true
Enrollment: 500 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Regionshospital Nordjylland
Principal Investigators:
  • Steen Hylgaard Jørgensen, MD (PRINCIPAL_INVESTIGATOR) - Department of Cardiology
Contact Information
Study Contact:
Peter Leutscher, Professor
0045 9764 2652
p.leutscher@rn.dk
Isabelle Larsen, RN
0045 2041 6541
isml@rn.dk
Interventions
N/A
Study Locations (1 sites)
North Denmark Regional Hospital, Hjørring, 9800 Denmark
Eligibility Criteria
Inclusion Criteria: * Type 2 diabetes * age \> 50 years Exclusion Criteria: * History of acute or chronic heart failure * History of ischemic heart disease
Trial to Evaluate Efficacy+Safety of Revita DMR Treatment Paradigm 1 and Retreatment in Type 2 Diabetes Patients
NCT06092476
Active, positions filled
Conditions Diabetes Mellitus, Type 2
Phase NA
Enrollment 18
Locations 1 sites
Compensation compensation available
Data Updated 2026-09-15
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The objective of this study is to evaluate feasibility, safety, and efficacy of endoscopic DMR Treatment Paradigm 1 (compared to sham) and to evaluate feasibility, safety, and efficacy of re-treatment with DMR at 24 weeks (compared to baseline and a single DMR procedure) in patients with type 2 diabetes with non-insulin glucose lowering medications.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Crossover Primary purpose: Treatment Masking/blinding: Quadruple

Interventions / Regimen

  • Device: Revita® DMR Treatment — The Revita® System is an endoscopic treatment consisting of a single catheter and console designed to lift the duodenal mucosa with saline followed by controlled circumferential hydrothermal ablation of the mucosa. For this study Revita® DMR procedure will be conducted as follows: DMR Treatment Paradigm 1- After initial 2 Lift and Ablate step, remaining Lift: Ablate steps will be conducted in 1:1 manner.
  • Other: Sham procedure — The sham control for the Revita DMR procedure.

Primary Outcomes

  • Safety endpoint (12 weeks post DMR and 12 weeks post retreatment with DMR)
  • Feasibility endpoint 1 (During procedure)
  • Feasibility endpoint 2 (During procedure)
  • Efficacy endpoint 1 (24 weeks post DMR/sham)
  • Efficacy endpoint 2 (24 weeks post DMR/sham)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2024-08-09
Completion: 2028-01-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 18 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators: Fractyl Health Inc.
Principal Investigators:
  • Jacques JG Bergman, MD, PhD (PRINCIPAL_INVESTIGATOR) - Amsterdam UMC
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Device: Revita® DMR Treatment — The Revita® System is an endoscopic treatment consisting of a single catheter and console designed to lift the duodenal mucosa with saline followed by controlled circumferential hydrothermal ablation of the mucosa. For this study Revita® DMR procedure will be conducted as follows: DMR Treatment Paradigm 1- After initial 2 Lift and Ablate step, remaining Lift: Ablate steps will be conducted in 1:1 manner.
  • Other: Sham procedure — The sham control for the Revita DMR procedure.
Study Locations (1 sites)
Amsterdam UMC, locatie VUmc, Amsterdam, Netherlands
Eligibility Criteria
Inclusion Criteria: 1. Diagnosed with Type 2 Diabetes. 2. Age ≥ 18 to ≤ 75 years. 3. Insulin naïve patients who are on stable dose (maximally approved or tolerated dose) of 2 or more glucose lowering drugs, including metformin, sulphonylurea (SU), (sodium-glucose cotransporter-2) inhibitors (SGLT-2i), Glucagon-like peptide-1 receptor agonists (GLP-1RA) or dipeptidyl peptidase 4 inhibitor (DPP-4i) and/or, thiazolidinedionderivaten (TZD) for at least 12 weeks. 4. BMI ≥ 24 and ≤ 40 kg/m2 5. HbA1c of ≥ 54 mmol/mol (7.5%) and ≤ 86 mmol/mol (10.0%). 6. Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation. Exclusion Criteria: 1. Uncontrolled hyperglycemia with a glucose level \>270 mg/dl (\>15.0 mmol/L) after an overnight 8-hour fasting at the end of run-in and confirmed by a second measurement on the consecutive day. 2. Subjects who are using insuline. 3. Known case of absolute insulin deficiency as indicated by a fasting plasma C-peptide value of \<0.6 ng/ml (\<0,2 nmol/L). 4. Diagnosis of autoimmune diabetes/Type 1 diabetes mellitus, monogenic (neonatal or maturity onset diabetes of the young (MODY)) diabetes or Type 1 diabetes in adults/latent autoimmune diabetes of adults (LADA). 5. History of more than 1 severe hypoglycemia episode or unawareness within past 6 months in which third party assistance was needed. 6. Clinically significant valvular heart disease or severe aortic stenosis. 7. Acute coronary syndrome (non-ST wave elevated myocardial infarction (STEMI), STEMI and unstable angina pectoris), stroke or transient ischemic attack within the past 3 months. 8. Indication of acute liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN). 9. Presence of acute or chronic active hepatitis B or C (except if hepatitis C is cured) or cirrhosis; or hepatic decompensation during the last 6 months; or alcoholic or autoimmune chronic hepatitis. 10. Impaired renal function, defined as estimated Glomerular Filtration rate (eGFR) \< 45 ml/min/1.73m2 or end stage renal failure or on dialysis. 11. Diagnosed with esophageal motility disorder or Glomerular Filtration rate (GERD) gr 3 or diagnosed during screening endoscopy. 12. Known history of a structural or functional disorder of the stomach, e.g. active gastric ulcer, chronic gastritis, gastric varices, hiatal hernia, stomach cancer or any other disorder of the stomach. 13. Previous GI surgery that could affect the ability to treat the duodenum such as patients who have had a Billroth 2, Roux-and-Y gastric bypass, gastric sleeve or other similar procedures. 14. Known intestinal autoimmune disease, including Celiac disease, or pre-existing symptoms of lupus erythematosus, scleroderma, or other autoimmune connective tissue disorder, which affects the small intestine. 15. Patients with active helicobacter pylori infection. Patients may be enrolled if they had history of h-pylori infection and were successfully treated. 16. History of active malignancy or partial remission from clinically significant malignancy within the past 5 years. With the exception of basal or squamous cell skin cancer or carcinoma in situ or those received curative treatment and in complete remission for 5 years or if subject confirmed as cancer free. 17. Blood dyscrasias or any disorders causing hemolysis or unstable Red Blood Cells (sickle cell trait is allowed). 18. Known case of severe peripheral vascular disease. 19. Clinically active systemic infection. 20. Known immunocompromised status, including individuals who have undergone organ transplantation, chemotherapy, or radiotherapy within the past 12 months, clinically significant leukopenia or positive for the human immunodeficiency virus (HIV), on potential immunosuppressants. 21. Current treatment with systemic steroids or change in dosage of thyroid hormones within 6 weeks prior to consent or any other uncontrolled endocrine disorder. 22. Use of anticoagulation therapy (such as warfarin, coumadin, Novel Oral AntiCoagulants (NOAC) or anti-platelet agents (such as thienopyridine) which cannot be discontinued for 5-7 days or 2 drug half-lives before the procedure; Acetylsalicylic acid does not need to be discontinued. 23. Actively participating in weight loss program or using medications for weight loss 3 months prior to randomization. 24. General contraindications to deep or conscious sedation or general anesthesia or high risk (e.g., American Society of Anesthesiologists Classification (ASA) 4 or higher) or contraindications to upper GI Endoscopy. 25. Nursing or Pregnant women or women of child bearing potential who are unwilling to practice acceptable method of birth control. 26. History of alcohol, legal or illegal drug and substance abuse. 27. Intake of an investigational drug in another trial within 30 days prior to consent or active participation in another clinical trial of an investigational drug or device. 28. Any other clinical or mental condition which would jeopardize subject's safety or makes subject a poor candidate for clinical trial participation.
GlucoBites Cookies (Gynura Procumbens) for Glycemic Control and Prevention of Diabetic Foot Ulcer Risk in Type 2 Diabetes
NCT07151833
Not yet recruiting
Conditions Type 2 Diabetes Mellitus, Diabetic Neuro...
Phase NA
Enrollment 126
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-15
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The goal of this randomized controlled trial is to learn if GlucoBites functional cookies containing Gynura procumbens can help improve blood sugar control and lower the risk of diabetic foot ulcers in adults with type 2 diabetes. The main questions are: * Do GlucoBites cookies lower fasting blood glucose and HbA1c? * Do GlucoBites cookies improve insulin resistance and vascular health? * Can GlucoBites reduce early signs that may lead to diabetic foot ulcers? Researchers will compare: * Intervention group: participants will eat 4 GlucoBites cookies every day for 12 weeks. * Control group: participants will continue standard diabetes care without GlucoBites. Participants will: * Visit the community health center for blood tests and foot health checks. * Be monitored for blood sugar, insulin resistance, lipid profile, and vascular function. * Be assessed for early risk of diabetic foot ulcer development. This study will help determine if a functional food innovation can support diabetes care and prevent complications.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Prevention Masking/blinding: Quadruple

Interventions / Regimen

  • Dietary Supplement: GlucoBites (with Gynura procumbens) — Participants receive 4 cookies per day for 12 weeks. The cookies contain standardized Gynura procumbens extract.
  • Dietary Supplement: Control Cookies (without Gynura procumbens) — Participants consume 4 cookies per day for 12 weeks. The cookies are identical in packaging, size, weight, and flavor to the GlucoBites cookies but do not contain Gynura procumbens.

Primary Outcomes

  • Fasting Blood Glucose (FBG) (Baseline and 12 weeks after intervention)
  • Change in HOMA-IR (Baseline and 12 weeks after intervention)
  • MMP-9/TIMP-1 Ratio (Baseline and 12 weeks after intervention)
  • Ankle-Brachial Index (ABI) (Baseline and 12 weeks after intervention)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2025-09-20
Completion: 2026-01-20
Eligibility
Age: 20 Years
Sex: ALL
Volunteers: false
Enrollment: 126 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Andina Setyawati
Contact Information
Study Contact:
Andina Setyawati, Dr
+628121521639
andina@unhas.ac.id
Interventions
  • Dietary Supplement: GlucoBites (with Gynura procumbens) — Participants receive 4 cookies per day for 12 weeks. The cookies contain standardized Gynura procumbens extract.
  • Dietary Supplement: Control Cookies (without Gynura procumbens) — Participants consume 4 cookies per day for 12 weeks. The cookies are identical in packaging, size, weight, and flavor to the GlucoBites cookies but do not contain Gynura procumbens.
Study Locations (1 sites)
Public Health Centre of Campagaloe, Bantaeng, South Sulawesi 92411 Indonesia
Eligibility Criteria
Inclusion Criteria: * Adults aged 20-70 years. * Diagnosed with type 2 diabetes mellitus (T2DM) based on ADA criteria. * HbA1c ≥ 7%. * At risk of diabetic foot ulcer (ABI \< 0.9 or early neuropathy signs). * Willing to consume study cookies and comply with study protocol. * Provided written informed consent. Exclusion Criteria: * Current use of herbal supplements or functional foods containing Gynura procumbens. * Presence of active diabetic foot ulcer or severe infection. * Severe cardiovascular, renal (eGFR \< 30 mL/min/1.73 m²), or hepatic impairment. * Pregnancy or breastfeeding. * Known allergy to ingredients in study cookies. * Participation in another clinical trial within the last 3 months.
Mitochondrial Substrate Utilization in the Diabetic Human Heart
NCT05958706
Recruiting
Conditions Heart Failure, Type2diabetes, Insulin Re...
Phase Not Applicable
Enrollment 500
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-15
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Diabetes can lead to heart failure independently, but the underlying causes remain incompletely understood. The main aim of this study is to identify differential regulation of mitochondrial substrate utilization and complex activity in heart failure and type 2 diabetes mellitus (T2DM). For this, we will conduct a prospective, observational study to examine myocardial mitochondrial oxidative function and related metabolic parameters, gene expression, histological markers, and inflammation in cardiac tissue from patients with heart failure or patients after heart transplantation. We will further assess cardiac function using cardiac magnetic resonance imaging with and without stress protocols and magnetic resonance spectroscopy. Glycemic control/T2DM will be characterized by oral glucose tolerance tests. The results of this project will help to better understand the cellular mechanisms of the development of diabetic cardiomyopathy and contribute to the development of early diagnostic, as well as therapeutic approaches for the prevention and treatment of diabetic cardiomyopathy.

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Primary Outcomes

  • Substrate-specific JVO2 of ventricular myocardial mitochondrial oxidative capacity (at time of the endomyocardial biopsy procedure)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2021-12-01
Completion: 2035-06
Eligibility
Age: 20 Years
Sex: ALL
Volunteers: false
Enrollment: 500 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Heinrich-Heine University, Duesseldorf
Principal Investigators:
  • Malte Kelm, Prof. (STUDY_CHAIR) - Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf
  • Elric Zweck, MD (PRINCIPAL_INVESTIGATOR) - Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf
Contact Information
Study Contact:
Elric Zweck, MD
+492118118800
elric.zweck@med.uni-duesseldorf.de
Amin Polzin, MD
+49211811800
amin.polzin@med.uni-duesseldorf.de
Interventions
N/A
Study Locations (1 sites)
University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine, Düsseldorf, 40225 Germany
Eligibility Criteria
Inclusion Criteria: * Age ≥ 20 and ≤ 85 years * Male and female patients with manifest heart failure (NYHA II-IV) and clinical indication for myocardial biopsy or after transplantation and clinical indication for myocardial biopsy with or without type II diabetes mellitus or terminal (NYHA IV) heart failure with or without type II diabetes mellitus. * Written informed consent Exclusion Criteria: * Acute infectious diseases within the last 2 weeks before the examination * Autoimmune diseases or acute immunocompromising diseases (leukocytes \< 5000/μl) * Pregnancy * Use of alcohol or drugs (addiction), psychiatric diseases * Suspected or manifest AIDS (HIV); hepatitis B or C. * Liver disease not attributed to the presence of nonalcoholic fatty liver hepatitis or congestive hepatopathy in heart failure * Malignant cancer * Lack of capacity to give informed consent or lack of consent to participate in the study * For MRI study with drug stress: contraindications to the use of regadenoson, specifically: a) Hypersensitivity to the active ingredient or any of the other ingredients mentioned. b) Second- or third-degree atrioventricular (AV) block or sinus node dysfunction, unless these patients have a functioning pacemaker. c) Unstable angina that has not been stabilized with medication. d) Severe hypotension. e) Decompensated stages of heart failure.
Nudge-Based Shared Decision Making and Self-Management in Type 2 Diabetes: A Randomized Trial
NCT07129915
Recruiting
Conditions Diabetes Mellitus, Type 2, Physician-Pat...
Phase NA
Enrollment 250
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-15
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This study aims to test whether a communication strategy called "linguistic nudging" can help doctors and patients with type 2 diabetes make better treatment decisions together, and whether this improves patients' ability to manage their condition. What will happen in the study? - 250 adults with type 2 diabetes from Xiang'an Hospital (Xiamen) will be randomly assigned to one of two groups: Intervention group:Doctors will receive special training in "linguistic nudging" techniques to encourage shared decision-making. Patients will use a mobile app to record medication preferences, and doctors will adjust advice based on these preferences. Control group:Patients will receive standard diabetes care without these additional strategies. \- All participants will be followed for 6 months. What is the study aiming to find out? The main goal is to see if patients in the intervention group: Better follow medication plans Improve blood sugar monitoring Have better blood sugar control Feel more satisfied with doctor-patient communication Why is this important? Good self-management is key to controlling diabetes, but many patients struggle with it. Effective communication during shared decision-making may empower patients to manage their condition day-to-day with greater confidence. Patient safety and rights: Participation is completely voluntary All personal information will be kept strictly confidential Medical support will be provided if any health problems occur during the study Participants may withdraw at any time This research has been approved by the Ethics Committee of Xiang'an Hospital (Approval date: October 2025).

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Health Services Research Masking/blinding: None

Interventions / Regimen

  • Behavioral: Linguistic Nudging Training — Physicians receive 4-hour communication training to optimize shared decision-making using behavioral nudging techniques
  • Device: Medication Preference App — Patients use WeChat-based mini-program to record daily medication preferences and concerns
  • Other: Standard Diabetes Care — Routine follow-up visits, HbA1c monitoring, and basic health education per hospital protocol

Primary Outcomes

  • Change in Glycated Hemoglobin (HbA1c) Level (Baseline and Month 6)
  • Diabetes Self-Management Capacity Scale Score (Baseline, Month 3, Month 6)
  • Shared Decision Making Questionnaire (SDM-Q-9) Score (Baseline)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-11-01
Completion: 2026-06
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 250 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Yunxuan Li
Contact Information
Study Contact:
Wei WANG, M.D.
+8613939809540
wwei19742007@hotmail.com
Yunxuan Li, Master Candidate
+8613939809540
yunxuanli@stu.xmu.edu.cn
Interventions
  • Behavioral: Linguistic Nudging Training — Physicians receive 4-hour communication training to optimize shared decision-making using behavioral nudging techniques
  • Device: Medication Preference App — Patients use WeChat-based mini-program to record daily medication preferences and concerns
  • Other: Standard Diabetes Care — Routine follow-up visits, HbA1c monitoring, and basic health education per hospital protocol
Study Locations (1 sites)
Xiang'an Hospital Affiliated to Xiamen University, Xiamen, Fujian 0592361101 China
Eligibility Criteria
Inclusion Criteria: * Confirmed diagnosis of type 2 diabetes * Age ≥ 18 years * Normal cognitive function (assessed by Mini-Cog score ≥ 3) * Basic smartphone operation ability (can independently use WeChat) * Willing to participate and sign informed consent Exclusion Criteria: * Severe acute complications (e.g., ketoacidosis, hyperosmolar coma) * Documented cognitive impairment (dementia, Alzheimer's, etc.) * Currently participating in other clinical trials * Life expectancy \< 6 months * Pregnancy or lactation
Surgical TreAtment for Obesity Related Disease and Onco-Metabolic Surgery
NCT04284943
Recruiting
Conditions Gastric Cancer, Diabetes Mellitus, Type ...
Phase NA
Enrollment 120
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-15
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This is a prospective, multi-center, randomized controlled trial to compare Billroth II reconstruction versus conventional Roux-en-Y reconstruction versus long limb Roux-en-Y reconstruction for glycemic control in patients with concurrent type 2 diabetes and gastric cancer.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Procedure: Long limb Roux-en-Y reconstruction after subtotal gastrectomy — The jejunum will be divided approximately 150 cm distal to the ligament of Treitz (Length of biliopancreatic limb). The gastrojejunostomy will be performed by end-to-end anastomosis and an anastomosis of the proximal end of the jejunum to the distal jejunum will be created approximately 50 cm distal from the gastrojejunal anastomosis (Length of Roux-en-Y limb).
  • Procedure: Conventional Roux-en-Y reconstruction after subtotal gastrectomy — The jejunum will be divided approximately 20 cm distal to the ligament of Treitz (Length of biliopancreatic limb). The gastrojejunostomy will be performed by end-to-end anastomosis and an anastomosis of the proximal end of the jejunum to the distal jejunum will be created approximately 30-45 cm distal from the gastrojejunal anastomosis (Length of Roux-en-Y limb).
  • Procedure: Billroth II reconstruction after subtotal gastrectomy — The duodenum will be transected approximately 2 cm distal to the pylorus and anastomosis will be performed between the gastric remnant and a loop of jejunum chosen approximately 20 cm distal to the ligament of Treitz (Length of afferent loop)

Primary Outcomes

  • The success rate of biochemical improvement of diabetes as measured by HbA1c < 6.5% (12 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2020-12-01
Completion: 2027-12
Eligibility
Age: 20 Years
Sex: ALL
Volunteers: false
Enrollment: 120 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Korea University Anam Hospital
Collaborators: Korea University Ansan Hospital, Korea University Guro Hospital, Chonnam National University Hospital, Kyung Hee University Hospital at Gangdong, Ajou University
Principal Investigators:
  • Sungsoo Park, MD, PhD (PRINCIPAL_INVESTIGATOR) - Korea University Anam Hospital
Contact Information
Study Contact:
Sungsoo Park, MD, PhD
+82 2 920 6772
kugspss@korea.ac.kr
Yeongkeun Kwon, MD, PhD
+82 2 920 6772
kukwon@korea.ac.kr
Interventions
  • Procedure: Long limb Roux-en-Y reconstruction after subtotal gastrectomy — The jejunum will be divided approximately 150 cm distal to the ligament of Treitz (Length of biliopancreatic limb). The gastrojejunostomy will be performed by end-to-end anastomosis and an anastomosis of the proximal end of the jejunum to the distal jejunum will be created approximately 50 cm distal from the gastrojejunal anastomosis (Length of Roux-en-Y limb).
  • Procedure: Conventional Roux-en-Y reconstruction after subtotal gastrectomy — The jejunum will be divided approximately 20 cm distal to the ligament of Treitz (Length of biliopancreatic limb). The gastrojejunostomy will be performed by end-to-end anastomosis and an anastomosis of the proximal end of the jejunum to the distal jejunum will be created approximately 30-45 cm distal from the gastrojejunal anastomosis (Length of Roux-en-Y limb).
  • Procedure: Billroth II reconstruction after subtotal gastrectomy — The duodenum will be transected approximately 2 cm distal to the pylorus and anastomosis will be performed between the gastric remnant and a loop of jejunum chosen approximately 20 cm distal to the ligament of Treitz (Length of afferent loop)
Study Locations (1 sites)
Korea University Anam Hospital, Seoul, 02841 South Korea
Eligibility Criteria
Inclusion Criteria: * Distal gastric adenocarcinoma diagnosed pathologically under preoperative endoscopic biopsy, and clinical stage I-II * Body mass index ≥ 23 kg/m2 * Type 2 diabetes and HbA1c ≥ 6.5% Exclusion Criteria: * Insulin usage for glycemic control at the time of screening evaluation * Prior gastrointestinal surgery including splenectomy, hepatobiliary and pancreatic surgery (except hemorrhoidectomy, herniorrhaphy, and appendectomy) * Abdominal, thoracic, pelvic and/or obstetric-gynecologic surgery within 3 months * Cardiovascular conditions including significant known CAD, uncompensated congestive heart failure, history of stroke, or uncontrolled hypertension. Subjects with CAD that have been successfully treated with CABG or PCI, and have no evidence of active ischemia are eligible * Kidney disease including renovascular hypertension, renal artery stenosis, or end-stage renal disease * Chronic liver disease including liver cirrhosis, alpha-1 antitrypsin deficiency * Gastrointestinal disorders including inflammatory bowel disease (Crohn's disease or ulcerative colitis) or any malabsorptive disorders * Psychiatric disorders including dementia, active psychosis, history of suicide attempts, alcohol or drug abuse within 12 months * Severe pulmonary disease defined as FEV1 \<50% of predicted value * Anemia defined as hemoglobin less than 8 in females and 10 in males * Malignancy within 5 years (except squamous cell and basal cell cancer of the skin). Subjects diagnosed with early or stage I cancer than have been successfully treated are eligible per investigator discretion * Frail elderly (Rockwood Clinical Frailty Scale ≥5) * Any condition or major illness that, in the investigator's judgement, places the subject at undue risk by participating in the study * Unable to understand the risks, realistic benefits and compliance requirements of each program * Use of investigational therapy or participation in any other clinical trial within 3 months * Geographic inaccessibility * Pregnancy
LIving BEtteR With asThma studY:: A Multimodal Intervention to Address Multimorbidity in Difficult Asthma
NCT06513117
Not yet recruiting
Conditions Asthma, Multi Morbidity
Phase NA
Enrollment 30
Locations 0 sites
Compensation Compensation typically provided
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Multimorbidity is a significant issue for many patients with difficult asthma. With patients, we have co-designed a multimodal intervention comprising prescribed exercise, dietary support, breathing pattern retraining and behaviour change to target multimorbidity in difficult asthma

Design

Study type: Interventional Phases: Allocation: Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Behavioral: Behaviour change — healthy conversations to support behaviour change
  • Behavioral: Dietary support — Guidance on healthy eating
  • Behavioral: Breathing pattern retraining — guidance on breathing pattern in exercise
  • Behavioral: Exercise training — Exercise intervention prescribed to participant fitness level

Primary Outcomes

  • Improvement in Asthma Control Questionnaire score (pre and post intervention, at 12 month follow up)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2024-10
Completion: 2028-04
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Southampton
Collaborators: University Hospital Southampton NHS Foundation Trust
Principal Investigators:
  • Anna Freeman, MBBS PhD (PRINCIPAL_INVESTIGATOR) - University of Southampton
Contact Information
Study Contact:
Anna Freeman, PhD MBBS
0238120 5232
a.freeman@soton.ac.uk
Ramesh Kurukulaaratchy, MBBS MD
0238120 5232
R.J.Kurukulaaratchy@soton.ac.uk
Interventions
  • Behavioral: Behaviour change — healthy conversations to support behaviour change
  • Behavioral: Dietary support — Guidance on healthy eating
  • Behavioral: Breathing pattern retraining — guidance on breathing pattern in exercise
  • Behavioral: Exercise training — Exercise intervention prescribed to participant fitness level
Eligibility Criteria
Inclusion Criteria: Aged 18 to 80 years Able and willing to give informed consent Diagnosis of asthma determined by 1. clinical diagnosis of difficult asthma as defined by BTS steps 4-5 and 2. enrolled in WATCH or meet WATCH inclusion criteria. 3. Demonstration of suboptimal symptom control through an ACQ ≥ 1.5 at enrolment 4. Normal lung function or mild/moderate airflow obstruction at baseline (FEV1\>50% predicted) 5. Not achieving WHO recommendations for physical activity for people living with chronic health conditions(62) (150-300 minutes of moderate-intensity aerobic physical activity; or at least 75-150 minutes of vigorous-intensity aerobic physical activity; or an equivalent combination of moderate- and vigorous-intensity activity throughout the week) 6)12 lead ECG without clinically significant abnormality - Exclusion Criteria: 1. Intercurrent exacerbation or exacerbation within 4 weeks prior to enrolment in study requiring treatment with oral corticosteroids and/or antibiotics. Note participants can be rescreened 4 weeks post exacerbation if they had not commenced the study 2. Initiation of biologic treatment within 6 months prior to recruitment or during study participation 3. Investigator determined significant change in regular asthma medication in the 12 weeks preceding or during trial period 4. Other medical or psychiatric conditions (including cognitive decline) limiting ability to exercise or that may in the opinion of the study clinician carry inherent risk for exercise 5. Contraindication to ISWT 6. Positive pregnancy test 7. Beta blocker treatment (due to impact on exercise prescription using HR) -
Remission in Adults With Mild-to-moderate Asthma in Thailand
NCT07351916
Recruiting
Conditions Asthma, Mild-to-moderate Asthma, Asthma ...
Phase Not Applicable
Enrollment 289
Locations 2 sites
Compensation Compensation varies
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The goal of this observational study is to determine the prevalence of remission among adults with mild-to-moderate asthma, as well as the factors associated with remission in Thailand. The main question the study aims to answer is: What is the prevalence of remission among adults with severe asthma in Thailand? Participants will complete a questionnaire on asthma symptoms and undergo pulmonary function testing and a blood test once.

Design

Study type: Observational Observational model: Cohort Time perspective: Cross Sectional

Interventions / Regimen

  • Other: Global Initiative for Asthma (GINA) and Asthma Control Test (ACT) questionnaires — GINA and ACT are questionnaires used to assess the level of asthma control.
  • Other: Spirometry — Spirometry is a tool used to assess pulmonary function.
  • Other: Fractional exhaled nitric oxide (FeNO) test — FeNO is a tool used to assess eosinophilic airway inflammation and asthma remission.
  • Other: Blood eosinophil count (BEC) — BEC is a tool used to assess eosinophilic inflammation and asthma remission.

Primary Outcomes

  • Prevalence rate of mild-to-moderate asthma remission (An average of 1 year)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2026-02-01
Completion: 2026-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 289 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Thammasat University
Principal Investigators:
  • Narongkorn Saiphoklang, MD (PRINCIPAL_INVESTIGATOR) - Thammasat University Faculty of Medicine
Contact Information
Study Contact:
Narongkorn Saiphoklang, MD
+6629269794
M_narongkorn@hotmail.com
Sirashat Hanvivattanakul, MD
+6629269701
boss32_@hotmail.com
Interventions
  • Other: Global Initiative for Asthma (GINA) and Asthma Control Test (ACT) questionnaires — GINA and ACT are questionnaires used to assess the level of asthma control.
  • Other: Spirometry — Spirometry is a tool used to assess pulmonary function.
  • Other: Fractional exhaled nitric oxide (FeNO) test — FeNO is a tool used to assess eosinophilic airway inflammation and asthma remission.
  • Other: Blood eosinophil count (BEC) — BEC is a tool used to assess eosinophilic inflammation and asthma remission.
Study Locations (2 sites)
Narongkorn Saiphoklang, Pathum Thani, Changwat Pathum Thani 12120 Thailand
Faculty of Medicine, Thammasat University, Pathum Thani, 12120 Thailand
Eligibility Criteria
Inclusion Criteria: * mild-to-moderate asthma * age 18 years or older Exclusion Criteria: * inability to perform spirometry or fractional exhaled nitric oxide (FeNO) test
The Use of Entropy to Assess Sleep Disordered Breathing in Chronic Respiratory Disease
NCT07060079
Recruiting
Conditions Bronchial Asthma, Bronchiectasis, ILD, C...
Phase Not Applicable
Enrollment 120
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Research is being conducted into chronic respiratory diseases, including chronic obstructive pulmonary disease (COPD), asthma, interstitial lung disease, and bronchiectasis. The investigation specifically focuses on sleep-disordered breathing (SDB) in individuals with chronic respiratory disease. SDB encompasses a range of conditions, the most common of which is obstructive sleep apnoea. In obstructive sleep apnoea, periodic pauses in breathing (apnoea) lead to reduced blood oxygen levels. To detect these events, patients typically undergo sleep studies that involve monitoring oxygen saturation, heart rate, and respiratory patterns during sleep. When chronic respiratory disease and SDB coexist, breathing disturbances during sleep may be exacerbated. To identify SDB, sleep studies are commonly used to assess oxygen levels, heart rate, and breathing patterns. The objective of this research is to identify differences between patients with chronic respiratory diseases who have SDB and those who do not. This will be achieved by analysing sleep study data using a novel analytical approach. The aim is to determine whether this method can yield more detailed insights into the underlying pathophysiology of these conditions.

Design

Study type: Observational Observational model: Other Time perspective: Prospective

Primary Outcomes

  • Changes in respiratory signals entropy, oxygen saturation , and heart rate recorded using cardiorespiratory polygraphy during a 1-hour daytime and overnight sleep in healthy subjects and patients with chronic respiratory diseases with /without SDB. (2 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2025-04-30
Completion: 2026-09-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 120 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University College, London
Collaborators: Royal Free Hospital NHS Foundation Trust
Contact Information
Study Contact:
Nawal Alotaibi
02080168375
n.alotaibi@ucl.ac.uk
Interventions
N/A
Study Locations (1 sites)
Royal Free hospital, London, NW3 2QG United Kingdom
Eligibility Criteria
Inclusion Criteria: * All adult patients (≥ 18years) with chronic respiratory disease with/without SDB. * patients who have had previously negative studies as a control group. * Subject is able to read, understand, and sign the informed consent form. * Willing to sleep with portable monitoring devices. Exclusion Criteria: * Patients who are under 18 years of age at the time of the index study. * Contraindications to the use of portable monitoring. * Inability to give informed consent to take part in the study.
Community Exercise Treating Effect on Cardiopulmonary Disease Patients
NCT07154355
Recruiting
Conditions Coronary Heart Disease (CHD), Heart Fail...
Phase NA
Enrollment 200
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The goal of this clinical trial is to learn if community-based exercise training can benefit patients aged 18 to 85 with diminished cardiovascular and pulmonary function. The main aim of this study is: • Establish a community or home-based fitness training program for patients with cardiopulmonary insufficiency to improve adherence, safety, and efficacy while alleviating the burden on both patients and society. Researchers will compare community-based exercise training to non-exercise training to see if community-based exercise training works to improve cardiovascular and pulmonary function. Participants will: * Engage in community or home exercise training for 40-60 minutes, five times weekly, during a duration of eight weeks. Exercise modalities are primarily determined by the patients' individual preferences and habits, such as brisk walking, running, swimming, cycling, and hiking. * Adjust the exercise intensity according to their cardiopulmonary exercise test and the person's perceived exertion level. * Utilize fitness bracelets or watches to document statistics during workouts and submit them to the experimenter weekly, covering the five days of exercise within that week. * refrain from making any dietary modifications throughout the trial.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Single

Interventions / Regimen

  • Behavioral: community-based exercise training — The patients will engage in 40-60 minutes of exercise training, either at home or in the community, five times a week, for eight weeks. Brisk walking, jogging, swimming, cycling, and trekking were among the exercise modalities that were chosen mostly based on the patient's individual preferences and habits. To guarantee safe and efficient exercise, exercise intensity was modified based on each person's subjective effort level and the results of their individual cardiorespiratory exercise tests.

Primary Outcomes

  • exercise capacity (at enrollment and week 8)
  • exercise capacity (at enrollment and week 8)
  • life quality (at enrollment and week 8)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-01-30
Completion: 2030-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 200 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Guangdong Provincial People's Hospital
Contact Information
Study Contact:
Bin Zeng
13538716788
zengbin@gdph.org.cn
Interventions
  • Behavioral: community-based exercise training — The patients will engage in 40-60 minutes of exercise training, either at home or in the community, five times a week, for eight weeks. Brisk walking, jogging, swimming, cycling, and trekking were among the exercise modalities that were chosen mostly based on the patient's individual preferences and habits. To guarantee safe and efficient exercise, exercise intensity was modified based on each person's subjective effort level and the results of their individual cardiorespiratory exercise tests.
Study Locations (1 sites)
Department of Rehabilitation Medicine Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Guangzhou, Guangdong 510080 China
Eligibility Criteria
Inclusion Criteria: 1. Patients aged 18 to 85 with abnormal pulmonary or cardiovascular function. 2. Individuals who have completed a medical screening form to confirm they are free from illnesses and prescription medications that could impair their ability to complete the required testing and fitness training. 3. Participants who did not engage in structured, systematic moderate-to-intense strength or endurance training during the study period (specifically, not within the previous year). 4. At the onset of the trial, participants were physically active but had never participated in formal exercise more than twice a week. Exclusion Criteria: 1. Patients with neuromuscular or skeletal disorders, or systemic diseases such as diabetes, cancer, or heart disease. 2. Individuals using medications known to affect health or the interpretation of study results. 3. Participants who have engaged in organized, systematic endurance or strength training of moderate to high intensity within the past year. 4. Patients who decline to participate in the study. 5. Other medical conditions or states that render exercise training inappropriate.
A Cohort Study of Risk Factors and Prognosis for Frequent Acute Asthma Exacerbations Phenotype
NCT06621056
Recruiting
Conditions Asthma Exacerbations
Phase Not Applicable
Enrollment 300
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Acute asthma exacerbations are an important public health problem and a major cause of disease progression and healthcare burden for people with asthma. Frequent acute exacerbations are likely to be a distinct asthma phenotype. Further research is needed to identify risk factors for frequent acute exacerbations, but previous studies have mostly been cross-sectional studies at a single time point or prospective studies based on smaller sample sizes. Moreover, most of the studies on frequent acute exacerbations have been conducted in severe or refractory asthma, whereas a certain proportion of non-severe asthmatics may also experience frequent acute exacerbations, the risk factors of which remain to be further evaluated. The main objectives of this project are to compare the baseline clinical, inflammatory, pathophysiological, comorbidities, environmental pollutants and meteorological exposure characteristics of patients with frequent acute exacerbations and those with non-frequent acute exacerbations irrespective of asthma severity, and to develop a disease prediction model for frequent acute exacerbations; and to develop a cohort of patients with frequent acute exacerbations of asthma, observe their prognosis and response to treatment, and search for prognostic factors associated with them. The successful implementation of this study will help in the early identification of patients with frequent acute exacerbations, clarify the factors associated with poor prognosis in this group of patients, and thus provide an individualized plan for the treatment and prevention of this type of patients, which is of great significance in achieving good asthma control, reducing the burden of disease, decreasing the cost of healthcare, and saving clinical healthcare resources and costs.

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Interventions / Regimen

  • Other: not applicable for observational research — This is an observational research and has no intervention

Primary Outcomes

  • acute asthma exacerbation (baseline and during 1 year follow-up)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2022-01-01
Completion: 2025-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 300 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Peking University Third Hospital
Contact Information
Study Contact:
Chun Chang
19800300860
doudou1977bysy@sina.com
Interventions
  • Other: not applicable for observational research — This is an observational research and has no intervention
Study Locations (1 sites)
Peking University third hospital, Beijing, Beijing Municipality 100191 China
Eligibility Criteria
Inclusion Criteria: * Patients with asthma attending the outpatient clinic of the Department of Respiratory and Critical Care Medicine of Peking University Third Hospital met the diagnostic criteria for asthma proposed by the guidelines for the prevention and treatment of bronchial asthma. Exclusion Criteria: * Combination of chronic obstructive pulmonary disease, bronchiectasis, pneumonia, obstructive sleep apnea hypoventilation syndrome, malignancy; combination of various acute and chronic respiratory failure; combination of severe cardiovascular disease; pregnant women.
A Cohort for Inflammatory Respiratory Diseases: From Phenotyping to Personalised Medicine
NCT07274631
Recruiting
Conditions Chronic Obstructive Pulmonary Disease, A...
Phase Not Applicable
Enrollment 470
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Chronic inflammatory pulmonary diseases, including asthma, chronic obstructive pulmonary disease (COPD), bronchiectasis, cystic fibrosis (CF), primary ciliary dyskinesia (PCD) and interstitial lung diseases (ILD) are characterised by lung inflammation and remodelling. Clinical, functional, microbiological, biological, pathological and prognostic features are highly variable and heterogeneous. Several phenotypes have been described within the same pathology, as similar phenotypic traits between different pathologies, or the coexistence of components of several diagnoses in the same patient, suggesting shared underlying mechanisms that could represent new therapeutic targets, beyond the initial medical diagnosis. The objectives of this prospective study are to analyze the phenotypic characteristics (clinical, demographic, biological, morphological, pathological, and microbiological characteristics) together with respiratory exposures and underlying mechanisms involving airway epithelium and inflammation processes in a cohort of patients diagnosed with asthma, COPD, bronchiectasis, CF, PCD and ILD.

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Interventions / Regimen

  • Other: Non applicable — Non applicable

Primary Outcomes

  • pheno-endotypes of inflammatory respiratory disease (Baseline)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2025-09-15
Completion: 2040-09-15
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 470 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: CHU de Reims
Contact Information
Study Contact:
Jeanne-Marie PEROTIN-COLLARD
03 10 73 67 63
jmperotin-collard@chu-reims.fr
Gaëtan DESLEE
03 26 78 76 11
gdeslee@chu-reims.fr
Interventions
  • Other: Non applicable — Non applicable
Study Locations (1 sites)
Chu Reims, Reims, 51092 France
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years * Follow-up for one of the following conditions: asthma, COPD, bronchiectasis (DDB), cystic fibrosis (CF), primary ciliary dyskinesia (PCD), or interstitial lung diseases (ILD) * Healthy volunteers (controls) Exclusion Criteria: * Subjects protected by law (e.g., legal incapacity) * Any condition preventing informed consent or participation
Intragastric Balloon in Obese Patients With Uncontrolled Asthma
NCT05364957
Recruiting
Conditions Obesity, Asthma
Phase NA
Enrollment 84
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The aim of this project is to study the effect of an intragastric balloon (IGB) on asthma control in obese patients. Obese patients with uncontrolled asthma will be recruited and randomly assigned to two intervention arms : an intragastric balloon combined with diet and exercise versus diet and exercise alone (control group). The primary endpoint will be the proportion of patients with an improvement based on an Asthma Control Questionnaire (ACQ) score ≥ 0.5 at 1 year compared to baseline.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Device: Intragastric balloon device — Patients in the experimental arm will benefit from the placement of an Intra Gastric Balloon endoscopically
  • Procedure: Dietary — The patient will benefit from dietary intervention that follows a standard medical recommendation; In consultation with a dietician (at M1, M4, M7, M13, M19, M25), patients will be asked to follow an appropriate diet with a balanced intake of macronutrients (55% carbohydrates, 30% lipids and 15% proteins).
  • Procedure: Exercise intervention — Patient will benefit from exercise intervention; Resistance and aerobic exercises will be performed twice a week for 3 months (between M4 and M7) under the supervision of a physiotherapist.

Primary Outcomes

  • Asthma Control Survey (12 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2023-05-12
Completion: 2029-08
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 84 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University Hospital, Toulouse
Principal Investigators:
  • Guilleminault M Laurent, MD (PRINCIPAL_INVESTIGATOR) - Study principal Investigator Toulouse University Hospital
Contact Information
Study Contact:
Guilleminault Laurent, MD
05 67 77 18 50
guilleminault.l@chu-toulouse.fr
Interventions
  • Device: Intragastric balloon device — Patients in the experimental arm will benefit from the placement of an Intra Gastric Balloon endoscopically
  • Procedure: Dietary — The patient will benefit from dietary intervention that follows a standard medical recommendation; In consultation with a dietician (at M1, M4, M7, M13, M19, M25), patients will be asked to follow an appropriate diet with a balanced intake of macronutrients (55% carbohydrates, 30% lipids and 15% proteins).
  • Procedure: Exercise intervention — Patient will benefit from exercise intervention; Resistance and aerobic exercises will be performed twice a week for 3 months (between M4 and M7) under the supervision of a physiotherapist.
Study Locations (1 sites)
University Hospital Toulouse, Toulouse, Occitanie 31000 France
Eligibility Criteria
Inclusion Criteria: 1. Men and women aged between 18 and 65 years 2. Asthma according to the Global Initiative for Asthma (GINA) criteria 3. Patients with uncontrolled asthma based on an ACQ score ≥1.5 despite inhaled corticosteroids ± long acting bronchodilators (LABA) 4. Patients with grade I obesity (BMI\> 30 kg/m² and \< 35 kg/m²) or morbid obesity (BMI\<40 or ≥35 kg/m² with serious physiological risks, as recommended by the French Health Authorities) with contraindications for or refusal of bariatric surgery. 5. Effective contraception for women 6. Patients who have signed a written informed consent form 7. Patients with health insurance 8. Complete COVID-19 vaccination schedule according to current guidelines Exclusion Criteria: 1. Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) 2. Blood eosinophilia greater than 4.5 G/I 3. Treatment by biotherapy within the 12 months after inclusion 4. Cancer diagnosed within the last 5 years 5. Smoking \> 10 packs/year (PA) 6. One asthma exacerbation in the 4 weeks leading up to the inclusion visit or IGB placement. 7. Treatment with orlistat Xénical® or GLP1 analogues or regular consumption of narcotics (heroin, cocaine and amphetamines). Analgesic treatments, including level 3, are authorized during the study. 8. Any patient for whom IGB is contraindicated \[criteria defined by the French Society for Digestive Endoscopy) and the French Think-Tank for Hepato-Gastroenterology Practices\]: 8.1 Severe cognitive or psychiatric disorders, chronic alcoholism, drug addiction 8.2 Severe and unstabilised eating disorders: bulimia or history of anorexia 8.3 History of gastric surgery including the ring insertion 8.4 Haemostasis disorders 8.5 Anticoagulant or non-steroidal anti-inflammatory medicines 8.6 Severe liver disease 8.7 Pregnancy or desire to become pregnant or breastfeeding 8.8 Anticipated failure to comply with prolonged medical follow-up 8.9 Large hiatal hernias \> 5 cm, inflammatory (Crohn's) or stenosing small bowel disease, pyloric stenosis and structural abnormalities of the digestive tract 8.10 Systemic lupus erythematous 8.11 Severe oesophagitis and active gastroduodenal ulcer 8.12 Silicone allergy 9. Patient under guardianship or tutorship, persons placed under the protection of justice or persons participating in another search including an exclusion period still in progress
Humidity Asthma Interventions for Low Socioeconomic Status Children
NCT07453667
Recruiting
Conditions Pediatric Asthma
Phase NA
Enrollment 80
Locations 2 sites
Compensation Compensation typically provided
Data Updated 2026-09-14
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Study Details Design, interventions, and primary outcomes

About This Study

The goal of this intervention study is to assess the effectiveness of low-cost humidity and mold reduction interventions in the home for reducing pediatric asthma. The study will have two groups, a treatment group that receives the healthy home interventions during the study and a second control group that will receive these after the study. We will compare pediatric asthma before and three months after the healthy home interventions are performed.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Prevention Masking/blinding: None

Interventions / Regimen

  • Other: Healthy home intervention — Healthy home interventions including low cost humidity interventions.

Primary Outcomes

  • Change in pediatric asthma control (Baseline and 3 months)
  • Change in asthma-related quality of life (Baseline and 3 months)
  • Hospitalizations (Baseline and 3 months)
  • Missing work/school (Baseline and 3 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2026-05-02
Completion: 2027-05
Eligibility
Age: No restriction
Sex: ALL
Volunteers: false
Enrollment: 80 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Case Western Reserve University
Collaborators: The Cleveland Clinic
Principal Investigators:
  • Bridget Hegarty, PhD (PRINCIPAL_INVESTIGATOR) - Case Western Reserve University
Contact Information
Study Contact:
Bridget Hegarty, PhD
216-368-2950
beh53@case.edu
Interventions
  • Other: Healthy home intervention — Healthy home interventions including low cost humidity interventions.
Study Locations (2 sites)
Case Western Reserve University, Cleveland, Ohio 44106 United States
Cleveland Clinic, Cleveland, Ohio 44195 United States
Eligibility Criteria
Inclusion Criteria: * Documented diagnosis of asthma by one child (\< 18 years of age) living within the home * Parent/guardian able to complete informed consent * Residence within the City of Cleveland or immediate suburbs (e.g., East Cleveland, Garfield Heights, Warrensville Heights, Parma, Brook Park, Brooklyn/Old Brooklyn) Exclusion Criteria: * \> 18 years of age * Rental property with landlord unwilling or unable to give consent for remediation
Controls for Respiratory Diseases
NCT03120481
Recruiting
Conditions Chronic Obstructive Pulmonary Disease, A...
Phase Not Applicable
Enrollment 1572
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This is the registry of control participants for patients with various respiratory diseases. We screened healthy volunteers who visited Seoul National Hospital Healthcare System Gangnam Center for routine health check-up, and enrolled patients who agree to participate in the study. The participants undergo baseline questionnaires, provide blood specimen and information of the results of health check-up. We will include participants as controls if they have no significant respiratory symptom and no significant radiographic abnormality. The data from this registry will be compared with those from other registry of various respiratory diseases

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Interventions / Regimen

  • Other: no intervation — no intervention

Primary Outcomes

  • Mortality (20 years)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2017-04-10
Completion: 2037-02-28
Eligibility
Age: 19 Years
Sex: ALL
Volunteers: true
Enrollment: 1572 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Seoul National University Hospital
Principal Investigators:
  • Chang-Hoon Lee, M.D. (PRINCIPAL_INVESTIGATOR) - Seoul National University Hospital
Contact Information
Study Contact:
Chang-Hoon Lee, M.D.
82-2-2072-4743
kauri670@gmail.com
Interventions
  • Other: no intervation — no intervention
Study Locations (1 sites)
Seoul National University Healthcare System Gangnam Center, Seoul, Seoul 06236 South Korea
Eligibility Criteria
Inclusion Criteria: * 19-90 years old male and female * underwent health check-up including chest radiography * obtained informed consent Exclusion Criteria: * those who showed a significant abnormal finding of chest radiography * those who reported a significant respiratory symptoms
Metformin IN Asthma for Overweight and Obese Individuals (MINA)
NCT06273072
Recruiting
Conditions Asthma, Asthma Chronic, Overweight and O...
Phase PHASE2
Enrollment 100
Locations 2 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This is a randomized clinical trial of metformin among overweight or obese adults with not well-controlled asthma despite maintenance inhaler therapy.

Design

Study type: Interventional Phases: Phase2 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Quadruple

Interventions / Regimen

  • Drug: Metformin hydrochloride extended-release tablets — titrated to 2000 mg once daily
  • Drug: Visually identical placebo Metformin hydrochloride extended-release tablets — placebo

Primary Outcomes

  • Number of completed telemedicine visits (Baseline to week 24)
  • Adherence to study drug (Baseline to week 24)
  • Retention rate (Baseline to week 24)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2024-12-09
Completion: 2028-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Johns Hopkins University
Collaborators: Baylor College of Medicine, National Heart, Lung, and Blood Institute (NHLBI), Temple University
Principal Investigators:
  • Meredith C McCormack, M.D., M.H.S. (PRINCIPAL_INVESTIGATOR) - Johns Hopkins University
  • Tianshi D Wu, M.D., M.H.S. (PRINCIPAL_INVESTIGATOR) - Baylor College of Medicine
Contact Information
Study Contact:
Rachelle Koehl, M.S.
410-955-1530
rkoehl1@jhmi.edu
Meredith C McCormack, M.D., M.H.S.
410-550-6205
mmccor16@jhmi.edu
Interventions
  • Drug: Metformin hydrochloride extended-release tablets — titrated to 2000 mg once daily
  • Drug: Visually identical placebo Metformin hydrochloride extended-release tablets — placebo
Study Locations (2 sites)
Johns Hopkins University, Baltimore, Maryland 21224 United States
Baylor College of Medicine, Houston, Texas 77030 United States
Eligibility Criteria
Inclusion Criteria: * Physician-diagnosed asthma on maintenance therapy * Not well-controlled asthma (ACT score \<20, or at least one asthma exacerbation requiring corticosteroids in the prior 12 months) * Overweight or obesity: Body mass index ≥25kg/m2 * Adult: Age ≥18 Exclusion Criteria: * Currently pregnant, expect to become pregnant in the next 6 months or are currently breastfeeding * Major cardiovascular disease: heart failure, heart attack or stroke within the last 6 months * Other chronic lung disease, inclusive of chronic obstructive pulmonary disease, bronchiectasis, interstitial lung disease, pulmonary fibrosis * Active smoking or former smoker with ≥20 pack-year smoking history * Chronic kidney disease: estimated glomerular filtration rate ≤60 mL/min/1.73 m2 * Heavy alcohol use: in a typical week, 8 or more drinks for a woman or 15 or more drinks for a man * Liver disease: elevation in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2x the upper limit of normal or prior diagnosis of liver disease * Anemia: hemoglobin \< 13 g/dl in males and hemoglobin \< 11 g/dl in females * Taking Glucagon Like Peptide 1(GLP-1) medications for weight loss * Diabetes (Hemoglobin A1C ≥ 6.5% or taking metformin or other medications used to treat diabetes) * Participation in any other clinical trial (observational studies are permitted)
Effects of a Pulmonary and Cardiovascular Rehabilitation Program
NCT06772922
Recruiting
Conditions Respiratory Muscle Weakness, Quality of ...
Phase NA
Enrollment 26
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-14
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Study Details Design, interventions, and primary outcomes

About This Study

Non-communicable chronic diseases (NCDs) affect approximately 30% of the adult global population, significantly impacting respiratory function and quality of life. Pulmonary and cardiovascular rehabilitation has proven to be an effective therapeutic intervention for managing respiratory symptoms and cardiovascular and improving functional capacity in patients with chronic respiratory conditions. The objective of this study is to evaluate the effects of the pulmonary and cardiovascular rehabilitation program on users of the physical therapy service of CECOM of UNICAMP related to functional capacity, quality of life and respiratory variables after 3 months of the program. Candidates for the pulmonary rehabilitation program are users diagnosed with chronic obstructive pulmonary disease (COPD), pulmonary emphysema, pulmonary fibrosis, asthma or other lung disease. Candidates for the cardiovascular rehabilitation program are users diagnosed with: infarction (AMI), myocardial revascularization surgery, coronary angioplasty, stable angina, valve replacement, chronic heart failure and who meet the criteria for phase III of cardiovascular rehabilitation. They should be referred to physical therapy by the cardiologist with complementary exams and exercise test. The program's assessment will consist of: anamnesis, analysis and recording of complementary exams, physical assessment (weight, height, BMI, cardiac and pulmonary auscultation, blood pressure, heart rate, peripheral oxygen saturation, respiratory muscle strength), functional capacity (six-minute walk test) and quality of life (questionnaire). The program will include aerobic exercises on a treadmill or stationary bike with an intensity between 50-70% of the reserve HR, below the ischemic thresholds. It will also include peripheral muscle strength exercises for the upper and lower limbs, in addition to respiratory muscle training for lung disease patients.

Design

Study type: Interventional Phases: Allocation: Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Other: Exercise — effect of exercise after three months (comparison of the patient with himself)

Primary Outcomes

  • Functional Capacity (three months)
  • Inspiratory muscle strength (three months)
  • Expiratory muscle strength (three months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2019-03-03
Completion: 2025-12-20
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 26 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Campinas, Brazil
Contact Information
Study Contact:
Letícia Baltieri
+55(19)35218936
lbaltieri@yahoo.com.br
Interventions
  • Other: Exercise — effect of exercise after three months (comparison of the patient with himself)
Study Locations (1 sites)
Unicamp, Campinas, São Paulo Brazil
Eligibility Criteria
Inclusion Criteria: * Candidates for the pulmonary rehabilitation program: users diagnosed with chronic obstructive pulmonary disease (COPD), pulmonary emphysema, pulmonary fibrosis, asthma or other lung disease. * Candidates for the cardiovascular rehabilitation program: users diagnosed with acute myocardial infarction, myocardial revascularization surgery, coronary angioplasty, stable angina, valve replacement, chronic heart failure and who meet the criteria for phase III of cardiovascular rehabilitation. * Referral with medical clearance for rehabilitation Exclusion Criteria: * Patients with any contraindication to aerobic or muscle-strengthening physical exercise, such as significant arrhythmias, untreated heart disease, myocarditis, recent or untreated pulmonary embolism, and uncontrolled systemic arterial hypertension, among other conditions.
Evaluation of 3D Magnetic Resonance Spirometry: Comparison with Spirometry in Healthy Subjects and Patients with Respiratory Pathologies (asthma, COPD, Bilateral Lung Transplant)
NCT05724745
Recruiting
Conditions Asthma, COPD, BOS
Phase NA
Enrollment 240
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Spirometry is now the gold standard technique for assessing lung function in humans. From the shape of a flow-volume curve measured while the patient, trained by the practitioner, performs forced breaths, the forced vital capacity (FVC) and the forced expiratory volume in one second (FEV1) can be deduced and the pulmonologist is able to detect and characterize respiratory diseases as well as to evaluate current treatments. This technique is non-invasive and simple. It is widely available, robust, reproducible and sensitive to intervention. However, it requires proactive cooperation from the patient and only measures global pulmonary ventilation, without locoregional information. An innovative strategy and an original study framework have been developed in the BioMaps laboratory to establish local maps of flow-volume curves across the lung and to jointly analyze ventilatory function and mechanical behavior at any point in the lung: 3D magnetic resonance spirometry. As respiratory mechanics fundamentally supports ventilatory function, this technique should open a new avenue to non-invasively explore lung function while providing a better diagnosis of regional lung diseases.

Design

Study type: Interventional Phases: Allocation: Intervention model: Single Group Primary purpose: Other Masking/blinding: None

Interventions / Regimen

  • Diagnostic Test: 1. Standard spirometry — Spirometry is performed in two positions (sitting and supine) and three types of breathing (spontaneous, forced and slow).
  • Diagnostic Test: 2. 3D dynamic lung MRI at UTE in prone and supine positions — Dynamic lung MRI is performed for 3D MR spirometry while the subject is lying prone and supine before a reversibility test with salbutamol.
  • Drug: 3. Reversibility test with salbutamol — Reversibility test with salbutamol administered using a pressurized metered dose bottle and an inhalation chamber at a dosage of 100 μg, 4 times (i.e., 400 μg in total).
  • Diagnostic Test: 4. 3D dynamic lung MRI at UTE in supine and prone position — Dynamic lung MRI is performed for 3D MR spirometry while the subject is lying prone and supine after the bronchodilatator's administration.

Primary Outcomes

  • Correlation between (1) spontaneous expiratory volume in 1 s (SEV1) and tidal volume (TV) and (2) FEV1 and FVC (2 months)
  • Difference of expiratory volume in 1 s (SEV1) and tidal volume (TV) between the left and right lungs (2 months)
  • Difference in expiratory volume in 1 s (SEV1) and tidal volume (TV) for the anterior-posterior, inferior-superior and medial-lateral lung regions (2 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2023-05-26
Completion: 2028-05
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 240 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Commissariat A L'energie Atomique
Contact Information
Study Contact:
MARTINS Bernadette
+33169087460
bernadette.martins@cea.fr
Interventions
  • Diagnostic Test: 1. Standard spirometry — Spirometry is performed in two positions (sitting and supine) and three types of breathing (spontaneous, forced and slow).
  • Diagnostic Test: 2. 3D dynamic lung MRI at UTE in prone and supine positions — Dynamic lung MRI is performed for 3D MR spirometry while the subject is lying prone and supine before a reversibility test with salbutamol.
  • Drug: 3. Reversibility test with salbutamol — Reversibility test with salbutamol administered using a pressurized metered dose bottle and an inhalation chamber at a dosage of 100 μg, 4 times (i.e., 400 μg in total).
  • Diagnostic Test: 4. 3D dynamic lung MRI at UTE in supine and prone position — Dynamic lung MRI is performed for 3D MR spirometry while the subject is lying prone and supine after the bronchodilatator's administration.
Study Locations (1 sites)
CEA | Service Hospitalier Fréderic Joliot, Orsay, France 91401 France
Eligibility Criteria
Inclusion Criteria: Generic inclusion criteria * Ability to understand the nature and objectives of the study * Ability to remain immobile in an MRI scanner in supine position for the entire duration of the acquisitions * Ability to give free and informed written consent Specific inclusion criteria for healthy volunteers * Age: 18-45 years * No known and diagnosed pulmonary pathology such as respiratory insufficiency, COPD, asthma or cancer * Ability to remain motionless in an MRI scanner in a prone position for a total of 50 min. * Non-smoker and non-smoker Specific inclusion criteria for asthma patients * Age: 18-80 years * Asthma of varying degrees of severity, depending on inhalation required to achieve control: * Diagnosis of asthma classified as moderate according to the Global initiative for asthma (GINA) guidelines for at least 6 months * Diagnosis of asthma classified as severe according to the Global initiative for asthma (GINA) guidelines for at least 6 months months with initiation of biotherapy planned by their pulmonologist * Non-smoker and non-vapourist Specific inclusion criteria for COPD patients * Age: 40-80 years * COPD of varying degrees of severity: * Diagnosis of COPD classified as moderate according to the Global initiative for chronic obstructive lung disease guidelines (GOLD 2: VEMS = 50-79%) * Diagnosis of COPD classified as severe according to the guidelines for chronic obstructive lung disease (GOLD 3: VEMS = 30-49%) Specific inclusion criteria for patients with bilateral lung transplants with BOS * Age: 18-90 years * Irreversible FEV1 \< 80% of baseline with FEV1/FVC ratio FEV1/FVC \< 0.7 * Absence of visible parenchymal opacity on CT scan (non inclusion of mixed RAS/CLAD) * Absence of significant bronchial stenosis (having required endoscopic endoscopic treatment) * No diaphragmatic involvement (established by sniff test under fluoroscopy fluoroscopy or diaphragmatic ultrasound) Specific inclusion criteria for patients with bilateral lung transplants without BOS * Age: 18-90 years * FEV1 \> 90% baseline for more than 24 months after the date of date of lung transplantation * Absence of significant bronchial stenosis (requiring endoscopic endoscopic treatment) * Absence of diaphragmatic impairment (established by sniff test under fluoroscopy or diaphragmatic ultrasound)