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Showing 20 of 27412 trials
A Study to Identify and Characterize Patients With Type 2 Diabetes Mellitus for Possible Participation in Ongoing or Future Type 2 Diabetes Mellitus Clinical Studies
NCT07606066
Recruiting
Conditions Type 2 Diabetes
Phase Not Applicable
Enrollment 2150
Locations 76 sites
Compensation Compensation varies
Data Updated 2026-09-10
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The purpose of this study is to identify and characterize patients with known Type 2 Diabetes Mellitus (T2DM) for possible participation in ongoing or future T2DM clinical studies, and to characterize trends in key concomitant medication use in this patient population across different geographical regions.

Design

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

Interventions / Regimen

  • Other: Procedure: assessment — The approximate volume of blood required is 2 mL

Primary Outcomes

  • Patient demographics (Visit 1 (Single day))
  • Medical and surgical history (Visit 1 (Single day))
  • Concomitant medication (Visit 1 (Single day))
  • HbA1c levels (Visit 1 (Single day))
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: 2026-05-06
Completion: 2027-03-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 2150 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: AstraZeneca
Contact Information
Study Contact:
AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com
Interventions
  • Other: Procedure: assessment — The approximate volume of blood required is 2 mL
Study Locations (76 sites)
Research Site, Peoria, Arizona 85382 United States
Research Site, Little Rock, Arkansas 72205 United States
Research Site, Lincoln, California 95648 United States
Research Site, Jacksonville, Florida 32256 United States
Research Site, Lake City, Florida 32055 United States
Research Site, Leesburg, Florida 34748 United States
Research Site, Ocoee, Florida 34761 United States
Research Site, Decatur, Georgia 30030 United States
Research Site, Melrose Park, Illinois 60160 United States
Research Site, El Dorado, Kansas 67042 United States
Eligibility Criteria
Inclusion Criteria: * Participants must be ≥ 18 years of age at the time of signing the ICF. * Patients with a diagnosis of T2DM, test- or documentation-confirmed as per World Health Organization or local diagnostic standards, inadequately managed with: 1. Lifestyle management alone, AND/OR 2. A stable dose of background glucose-lowering medication(s) for T2DM (As specified in the Protocol) for at least 45 days prior to signing the ICF. * Expresses interest in participating in an ongoing or future T2DM clinical study, is motivated and willing to make themselves available for the duration of the study, and is able to follow study procedures as required. * Provision of signed and dated written informed consent (As specified in the Protocol) before any study-specific procedures, sampling, or analysis. Exclusion Criteria: * Current or planned use of GLP-1 RAs prohibited in ongoing or future T2DM studies evaluating the efficacy and safety of investigational GLP-1 RAs (As specified in the Protocol). * Diagnosed with Type 1 diabetes mellitus. * Known pregnancy at the time of visit or having the intention to become pregnant.
Glucose, Understanding, Integrated Digital Health, and Engagement (GUIDE) Study
NCT07689877
Not yet recruiting
Conditions Diabetes, Diabetes Type 2
Phase NA
Enrollment 300
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-10
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Study Details Design, interventions, and primary outcomes

About This Study

The purpose of this study is to evaluate whether an Integrated Digital Health (IDH) intervention with and without healthcare provider engagement, improves glycemic control and diabetes-related outcomes among adults with Type 2 diabetes. The study will also assess the feasibility of integrating this approach into routine primary care to support personalized, data-informed diabetes management.

Design

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

Interventions / Regimen

  • Behavioral: Integrated Digital Health (IDH) platform — CGM, wearable for physical activity and sleep, food scan/log
  • Behavioral: Provider engagement — Weekly feedback through the IDH platform plus monthly video calls

Primary Outcomes

  • Mean Hemoglobin A1c (HbA1c) (Baseline, 16 weeks and 32 weeks)
  • Mean Glucose Variability (Coefficient of Variation [%CV]) (Baseline, 16 weeks and 32 weeks)
  • Percentage of glucose readings with Time in Range (TIR) (Baseline, 16 weeks and 32 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: 2026-08
Completion: 2031-03
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 300 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Yale University
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigators:
  • Soohyun Nam, PhD, APRN, ANP-BC, FAHA, FAAN (PRINCIPAL_INVESTIGATOR) - Yale University School of Nursing
Contact Information
Study Contact:
Soohyun Nam, PhD
203-737-2822
soohyun.nam@yale.edu
Interventions
  • Behavioral: Integrated Digital Health (IDH) platform — CGM, wearable for physical activity and sleep, food scan/log
  • Behavioral: Provider engagement — Weekly feedback through the IDH platform plus monthly video calls
Study Locations (1 sites)
Yale School of Nursing, New Haven, Connecticut 06477 United States
Eligibility Criteria
Inclusion Criteria: * diagnosis of T2D for at least one year * recent 3 month-HbA1c, 8-11% * ownership of a smartphone * English or Spanish speaking. Exclusion Criteria: * pregnant * not available or willing to use CGM or study device/platform * serious medical conditions or active thought disorders (e.g., terminal cancer, schizophrenia) In addition to the self-report of the HbA1c within the past 3 months, potential participants will be screened with a point-of-care (POC) HbA1c (A1CNow®+).
A Multicenter, Randomized, Open-Label, Parallel-Controlled Clinical Study Comparing the Efficacy and Safety of Cofrogliptin Versus Acarbose in Drug-Naïve Patients With Type 2 Diabetes
NCT07122102
Not yet recruiting
Conditions Type 2 Diabetes
Phase NA
Enrollment 200
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-10
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This study will compare the effect and safety of cofrogliptin (HSK7653) with acarbose among people with type 2 diabetes

Design

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

Interventions / Regimen

  • Drug: Cofrogliptin — 10mg administered once every two weeks
  • Drug: Acarbose — 50mg administered 3 times daily

Primary Outcomes

  • HbA1c (From enrollment to the end of treatment at 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: 2025-10-01
Completion: 2027-07-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 200 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Haisco Pharmaceutical Group Co., Ltd.
Contact Information
Study Contact:
Fangqiong Li
+86 028-67258
lifangq@haisco.com
Interventions
  • Drug: Cofrogliptin — 10mg administered once every two weeks
  • Drug: Acarbose — 50mg administered 3 times daily
Study Locations (1 sites)
He'nan Provincial People's Hospital, Zhengzhou, Henan China
Eligibility Criteria
Inclusion Criteria: * 1.Capable of understanding and voluntarily signing the written informed consent form. 2.Male or female aged ≥18 years (inclusive). 3.Fulfills diagnostic criteria for type 2 diabetes mellitus. 4.Previous glycemic control managed exclusively through diet and exercise therapy, with no prior exposure to any glucose-lowering or diabetes-related medications. 5.HbA1c at randomization: 7.0% ≤ HbA1c ≤ 9.0%. 6.Fasting plasma glucose (FPG) at randomization: FPG ≤ 11 mmol/L. 7.Body mass index (BMI) at randomization: 18 ≤ BMI ≤ 35 kg/m². 8.Agrees to maintain consistent dietary and exercise habits throughout the trial period. Exclusion Criteria: * 1.Known hypersensitivity to any component of the investigational product, chemically related compounds, or excipients. 2.History of diabetic ketoacidosis, type 1 diabetes, pancreatic/β-cell transplantation, or diabetes secondary to pancreatitis/pancreatectomy. 3.Acute coronary syndrome (STEMI/NSTEMI/unstable angina), stroke, or transient ischemic attack (TIA) within 3 months prior to informed consent. 4.Congestive heart failure (NYHA Class III-IV). 5.Uncontrolled hypertension (systolic BP ≥180 mmHg or diastolic BP ≥110 mmHg). 6.Hepatic impairment: ALT, AST, or ALP \>3×ULN at screening. 7.Severe renal impairment (eGFR \<25 mL/min/1.73m²). 8.Chronic gastrointestinal disorders with significant malabsorption. 9.Conditions potentially aggravated by intestinal gas (e.g., Roemheld syndrome, severe hernia, intestinal obstruction/ulceration). 10.Bariatric surgery or malabsorptive gastrointestinal procedures within past 2 years. 11.Anti-obesity medications within 3 months prior to consent or weight instability at screening. 12.Malignancy (except basal cell carcinoma) within 5 years and/or active cancer therapy. 13.HIV infection. 14.Severe peripheral vascular disease. 15.Hematological disorders causing hemolysis/erythrocyte instability (e.g., malaria, babesiosis, hemolytic anemia). 16.Current systemic corticosteroid use, thyroid hormone dose changes within 6 weeks, or uncontrolled endocrine disorders (excluding T2DM). 17.Substance abuse within 3 months or chronic conditions potentially compromising compliance. 18.Pregnancy, lactation, or unwillingness to use effective contraception (females/males). 19.Participation in other clinical trials within 30 days prior to screening. 20.Any other condition deemed unsuitable by the investigator.
Efficacy Heterogeneity of Lactobacillus Paracasei LC19 on Type 2 Diabetes
NCT07520305
Not yet recruiting
Conditions Type 2 Diabetes
Phase NA
Enrollment 70
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-10
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This is a single-arm study to investigate the heterogeneity of glycemic response to Lactobacillus paracasei LC19 in patients with newly diagnosed type 2 diabetes. Participants will receive LC19 for 12 weeks, and changes in glycemic control will be evaluated.

Design

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

Interventions / Regimen

  • Dietary Supplement: Lactobacillus paracasei LC19 Intervention — All participants will receive oral Lactobacillus paracasei LC19 powder (2 g/packet, 2 packets/day) for 12 weeks.

Primary Outcomes

  • HbA1c change (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: 2026-04-20
Completion: 2028-03-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 70 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Beijing Chao Yang Hospital
Principal Investigators:
  • Guang Wang (PRINCIPAL_INVESTIGATOR) - Beijing Chao Yang Hospital
Contact Information
Study Contact:
Jia Liu
010-85231710
liujia0116@126.com
Interventions
  • Dietary Supplement: Lactobacillus paracasei LC19 Intervention — All participants will receive oral Lactobacillus paracasei LC19 powder (2 g/packet, 2 packets/day) for 12 weeks.
Study Locations (1 sites)
Beijing Chao-yang Hospital, Capital Medical University, Beijing, Beijing Municipality 100020 China
Eligibility Criteria
Inclusion Criteria: * Age 18-65 years, both genders eligible * Drug-naive patients with newly diagnosed type 2 diabetes * Subjects with screening HbA1c ≥ 7.0% and ≤ 9.0% * Subjects understand the nature, significance, potential benefits, inconvenience, and risks and procedure of the study, and voluntarily sign the informed consent form Exclusion Criteria: * Other types of diabetes except T2D: type 1 diabetes (including adult latent autoimmune diabetes), special type diabetes, or secondary diabetes (such as acromegaly or Cushing\&amp;#39;s syndrome, etc.) * Subjects with acute diabetic complications such as diabetic ketoacidosis or diabetic hyperosmolar coma in the past 6 months * Subjects with history of hypoglycemia in the past 6 months * Subjects with history of New York Heart Association class (NYHA) grade of heart function ≥ III or serious cardiovascular diseases (myocardial infarction, or with the history of cardiac interventional therapy or stent implantation, valve disease or valve repair, unstable angina, transient ischemic attack or stroke) within 6 months before the screening period * Subjects with history of chronic active hepatitis and/or severe liver dysfunction, renal dysfunction, and thyroid dysfunction * Subjects with a medical history of malignant tumor * Subjects with history of gastrointestinal diseases that affect food digestion and absorption (such as severe diarrhea, constipation, irritable bowel syndrome, inflammatory bowel disease, active gastrointestinal ulcers, acute cholecystitis, etc.) or with a history of intestinal resection or other gastrointestinal surgery (such as cholecystectomy) within one year before the screening period * Subjects with history of surgery, or severe trauma in the past 6 months, or planning to undergo surgery during the study period * Subjects suffering from severe infections, severe anemia, or neutropenia * Subjects pregnant or in lactation, or those planning to become pregnant or impregnate during or within 3 months after the study period * Subjects with history of receiving immunosuppressants, steroids, anti diarrheal drugs, antibiotics, lipid-lowering drugs, or other gastrointestinal motility medications within the past 3 months * Subjects using other medications that can affect blood glucose in the past 3 months * Subjects with consumption of other probiotic or prebiotic products in the past 3 months before secreening * Subjects with lactose intolerance, known or suspected allergy to probiotics used in experiments, history of drug allergies or allergic diseases * Subjects with weight fluctuations ≥ 5kg in the past 3 months or planning to take medication to control weight during the study period * Subjects with history of mental illness or epilepsy, or taking antidepressant medications * Subjects with history of alcohol abuse (for men, alcohol consumption exceeding 40 grams per day and for women, exceeding 20 grams per day) * Subjects have participated in any other clinical study in the past 3 months
Diabetes Management for Primary Healthcare Centers.
NCT06907472
Active, positions filled
Conditions Type 2 Diabetes Mellitus (T2DM)
Phase NA
Enrollment 106
Locations 2 sites
Compensation Compensation typically provided
Data Updated 2026-09-10
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The purpose of this study, "Integrating diabetes care into Primary Healthcare Centers (PHCs) in Abuja, Nigeria: a pilot study," is to screen, diagnose, treat, and educate diabetes patients in two selected PHCs in Abuja. This single-arm pilot trial will test the feasibility of integrated diabetes care, measure the implementation outcomes, and explore the effectiveness of the strategy bundle using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.

Design

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

Interventions / Regimen

  • Drug: Protocol-based treatment — PROTOCOL: Step 1: Metformin 500 mg daily Step 2: Metformin 1000 mg daily Step 3: Metformin 1000 mg twice daily Step 4: Metformin 1000 mg twice daily + glibenclamide 5 mg daily Step 5: Metformin 1000 mg twice daily + glibenclamide 5 mg twice daily

Primary Outcomes

  • Reach (Recruitment rate): defined as the proportion of patients enrolled per month per the monthly recruitment target. (Six months.)
  • Adoption (adherence to protocol): defined as the proportion of diagnosed patients with diabetes started on treatment. (Six months.)
  • Maintenance (retention rate): defined as the proportion of patients who complete the six-month final visit of the implementation phase (Six months.)
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: 2025-09-15
Completion: 2026-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 106 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Abuja
Collaborators: Fogarty International Center of the National Institute of Health, Northwestern University, Washington University School of Medicine
Principal Investigators:
  • Ikechukwu A. Orji, MBBS, PhD (PRINCIPAL_INVESTIGATOR) - University of Abuja
  • Dike B. Ojji, MBBS, PhD (STUDY_CHAIR) - University of Abuja
  • Lisa R. Hirschhorn, MD, MPH (STUDY_DIRECTOR) - Northwestern University Chicago
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Drug: Protocol-based treatment — PROTOCOL: Step 1: Metformin 500 mg daily Step 2: Metformin 1000 mg daily Step 3: Metformin 1000 mg twice daily Step 4: Metformin 1000 mg twice daily + glibenclamide 5 mg daily Step 5: Metformin 1000 mg twice daily + glibenclamide 5 mg twice daily
Study Locations (2 sites)
Kagini PHC, Abuja Municipal Area council (AMAC), Abuja, Federal Capital Territory 900106 Nigeria
Deidei PHC, Bwari Area Council, Abuja, Federal Capital Territory 901101 Nigeria
Eligibility Criteria
Inclusion Criteria: * Adults 18 years and older * Uncomplicated type 2 diabetes mellitus Exclusion Criteria: * Minors (younger than 18 years), * Type 1 diabetes mellitus * Prisoners * Other detained individuals * Severe hypertension (SBP ≥180 mmHg and DBP ≥ 110 mmHg) * Prior history of complications: stroke, heart failure, chronic kidney disease, diabetic foot ulcer. * Pregnant women. * Older patients above 60 years of age with uncontrolled plasma glucose at the maximum dose of metformin (2 g/day) and maximum dose of glibenclamide (5mg/day) at entry to the study.
Changing Outpatient Diabetes Care With Remote-Patient-Monitoring: A Real World Evidence Study With Pre-Post Comparison
NCT07617519
Recruiting
Conditions Diabetes, Diabetes Care, Diabetes Type 1...
Phase Not Applicable
Enrollment 12000
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-10
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The goal of this observational pre-post study is to evaluate a remote-patient-monitoring-system (RPM-system) integrated within an electronic health record (EHR) system in a real world cohort of approximately 12.000 people with diabetes in an outpatient care setting. The main question it aims to answer is: Whether glycemic outcomes following integration of the RPM system into the EHR over a two-year period are non-inferior compared with outcomes observed prior to an ambulatory care restructuring (including a prototype of the RPM-system) in October 2024. Participants are included in the RPM-system as part of their regular medical care for diabetes.

Design

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

Interventions / Regimen

  • Other: Remote-Patient-Monitoring (RPM) — The RPM-system "Steno Detektor" integrated within the EHR-system

Primary Outcomes

  • Children: Composite Continuous-Glucose-Monitoring (CGM) endpoint consisting of Time-Above-Range (TAR) and Time-Below-Range (TBR) (From PRE-period (defined as 1. July 2023 to 30. June 2024) to POST-period (defined as 1. July 2027 - 30. June 2028).)
  • Adults with Type 1 diabetes: Composite Continuous-Glucose-Monitoring (CGM) endpoint consisting of Time-Above-Range (TAR) and Time-Below-Range (TBR) (From PRE-period (defined as 1. July 2023 to 30. June 2024) to POST-period (defined as 1. July 2027 - 30. June 2028).)
  • Adults with Type 2-diabetes: HbA1c (mmol/L) (From PRE-period (defined as 1. July 2023 to 30. June 2024) to POST-period (defined as 1. July 2027 - 30. June 2028).)
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: 2026-06-10
Completion: 2028-07
Eligibility
Age: No restriction
Sex: ALL
Volunteers: false
Enrollment: 12000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Steno Diabetes Center Copenhagen
Contact Information
Study Contact:
Jonatan I. Bagger, MD, Ph.d., Chief Physician
+45 28341036
jonatan.ising.bagger@regionh.dk
Julie E. Stenvang, MD, Ph.d.-student
+45 51429941
julie.christine.egelund.stenvang.01@regionh.dk
Interventions
  • Other: Remote-Patient-Monitoring (RPM) — The RPM-system "Steno Detektor" integrated within the EHR-system
Study Locations (1 sites)
Steno Diabetes Center Copenhagen, Herlev, 2730 Denmark
Eligibility Criteria
Inclusion Criteria: * All people with active clinical care at SDCC during each period and thereby included in the RPM. Exclusion Criteria: * All people without active clinical care at SDCC during each period.
Para-Probiotic Oral Care in Periodontal Patients With Type 2 Diabetes
NCT07069166
Recruiting
Conditions Periodontitis, Type 2 Diabetes Mellitus ...
Phase NA
Enrollment 40
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-10
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This randomized controlled clinical trial aims to evaluate the effectiveness of a para-probiotic-based oral care protocol in improving periodontal health and glycemic control in patients with type 2 diabetes mellitus (T2DM). A total of 40 adult patients (aged 18-70) with diagnosed periodontitis and T2DM will be enrolled and randomly assigned to two treatment groups. Both groups will receive standard non-surgical periodontal therapy. The test group will use para-probiotic toothpaste and mouthwash (Biorepair Plus Parodontogel and Biorepair Plus mouthwash) twice daily for 15 days after each recall visit, while the control group will use toothpaste and mouthwash containing 0.20% chlorhexidine on the same schedule. Clinical evaluations will be conducted at baseline (T0), 3 months (T1), and 6 months (T2), assessing key periodontal parameters including clinical attachment level (CAL), bleeding on probing (BoP), probing pocket depth (PPD), plaque index (PI), and glycemic control via hemoglobin A1c (HbA1c) levels. Patient satisfaction with treatment will be assessed using a questionnaire at T1 and T2. The primary objective is to evaluate the change in CAL from baseline to 6 months. Secondary objectives include the evaluation of changes in BoP, PPD, PI, HbA1c, and patient-reported satisfaction. This study seeks to determine whether para-probiotic oral care products can offer clinical benefits for periodontal disease management and systemic glycemic control in diabetic patients, potentially serving as a natural adjunct to conventional periodontal therapy.

Design

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

Interventions / Regimen

  • Drug: Para-probiotic oral care — This intervention includes the home use of a para-probiotic-based toothpaste (Biorepair Plus Parodontogel) and mouthwash (Biorepair Plus with para-probiotics), applied twice daily for 15 days after each recall visit, over a 6-month period. The products contain microRepair® (zinc hydroxyapatite), lactoferrin, zinc PCA, and para-probiotic extracts aimed at modulating the oral microbiota and improving periodontal health.
  • Drug: Chlorhexidine oral care — This intervention includes the home use of toothpaste and mouthwash containing 0.20% chlorhexidine digluconate, applied twice daily for 15 days after each recall visit, over a 6-month period. Chlorhexidine is used for its antimicrobial properties to control dental plaque and gingival inflammation.

Primary Outcomes

  • Change in mean Clinical Attachment Level (CAL) (Baseline (T0), 3-month follow-up (T1), and 6-month follow-up (T2))
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-07-30
Completion: 2026-06-10
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 40 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Pavia
Principal Investigators:
  • Andrea Scribante, Associate Professor (PRINCIPAL_INVESTIGATOR) - University of Pavia
Contact Information
Study Contact:
Andrea Scribante, Associate Professor
+39 0382516223
andrea.scribante@unipv.it
Interventions
  • Drug: Para-probiotic oral care — This intervention includes the home use of a para-probiotic-based toothpaste (Biorepair Plus Parodontogel) and mouthwash (Biorepair Plus with para-probiotics), applied twice daily for 15 days after each recall visit, over a 6-month period. The products contain microRepair® (zinc hydroxyapatite), lactoferrin, zinc PCA, and para-probiotic extracts aimed at modulating the oral microbiota and improving periodontal health.
  • Drug: Chlorhexidine oral care — This intervention includes the home use of toothpaste and mouthwash containing 0.20% chlorhexidine digluconate, applied twice daily for 15 days after each recall visit, over a 6-month period. Chlorhexidine is used for its antimicrobial properties to control dental plaque and gingival inflammation.
Study Locations (1 sites)
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia, Pavia, Lombardy 27100 Italy
Eligibility Criteria
Inclusion Criteria: * Age between 18 and 70 years * Diagnosis of periodontitis (Stage II or III; Grade B or C) * Presence of at least one periodontal pocket per side of the mouth, with a maximum of 20 teeth presenting pathological probing depths * Presence of both single- and multi-rooted teeth * Type 2 diabetes mellitus diagnosed at least one year prior to enrollment * Good general health status and ability to comply with study protocol * Written informed consent provided Exclusion Criteria: * Presence of cardiac pacemakers * History of neurological disorders * History of psychiatric disorders * Current pregnancy or breastfeeding * Steroid-induced diabetes mellitus * Inability or unwillingness to attend follow-up visits or adhere to home oral care instructions
Wild Blueberries for Gut, Brain, and Cardiometabolic Health in Prediabetes
NCT06735651
Recruiting
Conditions Prediabetes (Insulin Resistance, Impaire...
Phase NA
Enrollment 30
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-10
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The goal of this clinical trial is to determine the effectiveness of using a freeze-dried wild blueberry powder on cardiometabolic health, cognitive function, and gut microbiota composition in adult women with prediabetes.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Basic Science Masking/blinding: Triple

Interventions / Regimen

  • Dietary Supplement: Wild Blueberry — Daily consumption of 22 g of freeze-dried wild blueberry freeze-dried powder for 6 weeks
  • Dietary Supplement: Placebo — Daily consumption of 22 g of freeze-dried macronutrient-matched placebo powder for 6 weeks

Primary Outcomes

  • Blood Glucose (Baseline and 6 weeks)
  • Ambulatory Blood Pressure (Baseline and 6 weeks)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-09-20
Completion: 2027-09-01
Eligibility
Age: 20 Years
Sex: FEMALE
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Georgia State University
Collaborators: Wild Blueberry Association of North America
Principal Investigators:
  • Rafaela G Feresin, PhD (PRINCIPAL_INVESTIGATOR) - Georgia State University
Contact Information
Study Contact:
Rafaela G Feresin, PhD
404-413-1233
berries@gsu.edu
Interventions
  • Dietary Supplement: Wild Blueberry — Daily consumption of 22 g of freeze-dried wild blueberry freeze-dried powder for 6 weeks
  • Dietary Supplement: Placebo — Daily consumption of 22 g of freeze-dried macronutrient-matched placebo powder for 6 weeks
Study Locations (1 sites)
Georgia State University, Atlanta, Georgia 30303 United States
Eligibility Criteria
Inclusion Criteria: * Women aged 20-65 years old * Prediabetes (fasting blood glucose 100-125 mg/dL and/or HbA1c percentage between 5.7-6.4) * Body Mass Index between 25-30 kg/m\^2 Exclusion Criteria: * Allergies to berries * Use of insulin, antidiabetic, antibiotics, and anti-inflammatory drugs * Active cancer, gastrointestinal, renal, thyroid, stage 1 \& 2 hypertension and other cardiovascular diseases, neurological diseases, or severe head injury * Smoking * Consumes greater than 2 alcoholic beverages per day * Consumes antioxidant, probiotic, and prebiotic supplements * Pregnant or Lactating * Actively participating in a weight loss program * Currently taking berry supplements or recently participated in another study taking berry supplements
Nutrition Intervention Optimization to Better Utilize Resources and Support Health
NCT07713836
Not yet recruiting
Conditions Diabete Type 2, Obesity & Overweight, Nu...
Phase NA
Enrollment 400
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-10
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Not having enough food for each person in a household, also called food insecurity, makes it hard to eat a nutritious diet, maintain a healthy weight, and manage diabetes risk. Food banks and pantries provide direct food assistance that can mitigate food insecurity among people with lower income, however, people that utilize these organizations face time, resource, and physical constraints that limit their ability to consistently select and cook healthier meals and the organizations face budget constraints that limit their bandwidth for implementing nutrition programs. This research will test four innovative nutrition programs (nutritious prepared meals, medically tailored groceries in the form of meal kits, culinary medicine, motivational text messages) to identify which are the most effective for supporting healthy eating and food security and the most cost effective for organizations to implement, as an effort to reduce diabetes risk, improve diabetes self-management, and diminish health disparities.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Factorial Primary purpose: Other Masking/blinding: Single

Interventions / Regimen

  • Behavioral: Meal kits — Meal kits combine ingredients (e.g., chicken, tomatillo salsa verde, peppers, sweet potatoes) in a bag with a recipe that instructs how to make a healthier meal (e.g., Chicken Tomatillo Salsa Verde with Peppers and Sweet Potatoes).
  • Behavioral: No-prep meals — The meals were created to meet nutrition standards for people with or at-risk for cardiometabolic diseases. Each entree has at least one serving of proteins, whole grains, and two vegetables. Entrees are low in sodium and sugar and meet carbohydrate recommendations for people with diabetes.
  • Behavioral: Culinary nutrition classes — Participants randomly assigned to receive culinary nutrition classes will receive six-weeks of hybrid instruction from the Health Meets Food™ curriculum. Health Meets Food™ improves adherence to a nutritious diet, reduces food costs by encouraging more home food preparation, and reduces blood pressure and cholesterol among people with diabetes.
  • Behavioral: Text messages — Participants will receive four culturally tailored SMS and MMS texts per week with motivational messages and nutrition education developed and tested by Dr. Leng as part of the SANOS trial (R01MD012819) and slightly adapted to our community's food preferences identified through extensive preliminary research. Texts will be delivered in the participants preferred language (English/Spanish) and scheduled for their preferred time (e.g., AM/PM).

Primary Outcomes

  • Diet (Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period (Appt 3, month 6), and three months post-intervention (Appt 4, month 9).)
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: 2027-01
Completion: 2031-02
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 400 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Tufts University
Collaborators: University of Texas Southwestern Medical Center
Principal Investigators:
  • Kelseanna Hollis-Hansen, PhD, MPH (PRINCIPAL_INVESTIGATOR) - Tufts University
Contact Information
Study Contact:
NICHE Lab Team
‪(469) 240-9112‬
niche@tufts.edu
Interventions
  • Behavioral: Meal kits — Meal kits combine ingredients (e.g., chicken, tomatillo salsa verde, peppers, sweet potatoes) in a bag with a recipe that instructs how to make a healthier meal (e.g., Chicken Tomatillo Salsa Verde with Peppers and Sweet Potatoes).
  • Behavioral: No-prep meals — The meals were created to meet nutrition standards for people with or at-risk for cardiometabolic diseases. Each entree has at least one serving of proteins, whole grains, and two vegetables. Entrees are low in sodium and sugar and meet carbohydrate recommendations for people with diabetes.
  • Behavioral: Culinary nutrition classes — Participants randomly assigned to receive culinary nutrition classes will receive six-weeks of hybrid instruction from the Health Meets Food™ curriculum. Health Meets Food™ improves adherence to a nutritious diet, reduces food costs by encouraging more home food preparation, and reduces blood pressure and cholesterol among people with diabetes.
  • Behavioral: Text messages — Participants will receive four culturally tailored SMS and MMS texts per week with motivational messages and nutrition education developed and tested by Dr. Leng as part of the SANOS trial (R01MD012819) and slightly adapted to our community's food preferences identified through extensive preliminary research. Texts will be delivered in the participants preferred language (English/Spanish) and scheduled for their preferred time (e.g., AM/PM).
Study Locations (1 sites)
Crossroads Community Services, Dallas, Texas 75236 United States
Eligibility Criteria
Inclusion Criteria: * Aged 18+, * Body mass index (BMI)≥ 25; * Access to a device with SMS and MMS (picture) text and Wi-Fi capabilities (e.g., phone, tablet, computer) and willingness to use the device regularly during the study; * Willingness to complete four in-person data collection appointments; * Willing and able to consent. Exclusion Criteria: * Presence of a condition or dietary restriction precluding eating study meals or weight loss (e.g., condition requiring liquid diet, pregnancy); * Another member of the household participating; * Planning to move within the next 12 months; * Unwilling to participate.
Self Management of Type 2 Diabetes Using a Text Based Mobile Health (Mhealth) Intervention in Nepal
NCT06623006
Active, positions filled
Conditions Type 2 Diabetes Mellitus (T2DM)
Phase NA
Enrollment 154
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-10
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Background: The global prevalence of diabetes is increasing particularly in low and middle income countries like Nepal with the number expected to rise in the near future. Advances in technology have led to greater use of mobile health (mhealth) for managing chronic diseases. mhealth offers a cost-effective way to improve health outcomes with evidence supporting feasibility, acceptability and effectiveness in resource-limited settings like Nepal. However, while mhealth has shown promising results in promoting positive health behaviour and improving service utilization for chronic conditions, its potential for self-management of type 2 diabetes in Nepal is yet to be evaluated. This study thus aims to determine the effectiveness and acceptability of a text based mhealth intervention that improve self-management in people with Type 2 Diabetes in Nepal. Methods: This study is a 6 month, open-label, two-armed parallel group randomized control trial among 154 participants with type 2 diabetes. Participants will be randomly assigned to either intervention or control group on a 1:1 basis. The intervention group will receive a text based mhealth intervention (text messages) in addition to standard care while the control group will receive only standard care. Baseline data will be collected using a structured questionnaire. Follow up will be done 6 months after the intervention. The primary outcome of the study will be a difference in mean in the HbA1c level from baseline to follow up. The secondary outcomes include changes in diabetes self-care activities, self-efficacy, social-support, diabetes related stress, quality of life and acceptability of the intervention. An economic evaluation will be conducted using a patient perspective. Data will be analyzed using Stata version 13.0.

Design

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

Interventions / Regimen

  • Behavioral: mobile health (mhealth) — The intervention will include a text-based mhealth component, designed using a behaviour change framework (Behaviour Change Wheel). The development process will be further informed by a formative research exploring perspectives of both health service providers and users on use of text based mhealth for supporting self-management in people with type 2 diabetes.

Primary Outcomes

  • Change in HbA1c level (six months)
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: 2025-09-16
Completion: 2026-09-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 154 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Huddersfield
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Behavioral: mobile health (mhealth) — The intervention will include a text-based mhealth component, designed using a behaviour change framework (Behaviour Change Wheel). The development process will be further informed by a formative research exploring perspectives of both health service providers and users on use of text based mhealth for supporting self-management in people with type 2 diabetes.
Study Locations (1 sites)
Dhulikhel Hospital, Dhulikhel, Bagmati Nepal
Eligibility Criteria
Inclusion Criteria: * adults aged 18 years and above * clinical diagnosis of type 2 diabetes * participant who have a mobile phone and is able to read the message on their own or with the help of family members. Exclusion Criteria: * not physically or mentally able, not able to provide consent * pregnant in case of female
Coronal and Radicular Caries Prevalence and Related Risk Factor in Diabetic Patient
NCT06701565
Not yet recruiting
Conditions Caries,Dental, Caries Root, Diabetes Mel...
Phase Not Applicable
Enrollment 265
Locations 0 sites
Compensation Compensation varies
Data Updated 2026-09-10
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This study aims to investigate the prevalence and risk factors of coronal and radicular caries in middle-aged individuals with Type 2 diabetes. It focuses on how poor blood sugar control, reduced saliva production, increased plaque accumulation, and periodontal disease contribute to a higher risk of dental decay in this population. The study examines the relationship between glycemic control (e.g., HbA1c levels) and the severity of caries, as well as the impact of diabetes-related changes in oral health, such as gum recession and dry mouth, on the development of both coronal and radicular caries. The findings could inform preventive strategies and dental care guidelines tailored for diabetic patients.

Design

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

Primary Outcomes

  • prevalence of coronal caries (One year)
  • prevalence of radicular caries (One year)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Not yet recruiting
Start Date: 2024-12-15
Completion: 2025-06-15
Eligibility
Age: 35 Years
Sex: ALL
Volunteers: false
Enrollment: 265 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Cairo University
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
N/A
Eligibility Criteria
Inclusion Criteria: 1. Patient whose age between 30-65 2. Diabetic patients 3. Patient consulting in the outpatient clinic 4. Co-operative patient 5. Males \& Females 6. Egyptian Exclusion Criteria: 1. Patients under or over this age group 2. Lack of compliance 3. Disabilities 4. Pregnant women
Video-Based Lifestyle Counseling in Adults With Type 2 Diabetes.
NCT07557264
Not yet recruiting
Conditions Diabetes Mellitus (Type 2), Glycemic Con...
Phase NA
Enrollment 156
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-10
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This study evaluates the effectiveness of a 3-month video-based lifestyle intervention, focused on promoting healthy lifestyle habits (healthy eating and increased physical activity), on adults with type 2 diabetes mellitus (DM2). Participants will be randomly allocated to receive the intervention either delivered by their own physician (experimental group) or by a physician unknown to them (control group). Assessment will include sociodemographic variables, glycated hemoglobin / HbA1c (primary outcome), body mass index, blood pressure, glycemic and lipid metabolism variables, physical activity level, adherence to the Mediterranean diet, therapeutic alliance, and health-related quality of life. The randomization process will be stratified according to HbA1c, therapeutic alliance, age, and sex.

Design

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

Interventions / Regimen

  • Behavioral: Video-based lifestyle intervention (own physician) — The experimental group will receive the video-based lifestyle intervention delivered by their own physician, while the control group will receive identical content delivered by physicians unknown to the participants. The intervention consists of structured multimedia modules focusing on nutrition, physical activity, strength exercise, and psychological strategies to support behavior change.
  • Behavioral: Video-based lifestyle intervention (unknown physician) — The experimental group will receive the video-based lifestyle intervention delivered by their own physician, while the control group will receive identical content delivered by physicians unknown to the participants. The intervention consists of structured multimedia modules focusing on nutrition, physical activity, strength exercise, and psychological strategies to support behavior change.

Primary Outcomes

  • Glycated Hemoglobin (HbA1c) (Baseline (pre-intervention) and 3 months (post-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: 2026-09-01
Completion: 2027-05-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 156 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Cardenal Herrera University
Contact Information
Study Contact:
Juan Francisco Lisón
+34 96 136 90 00
juanfran@uchceu.es
Interventions
  • Behavioral: Video-based lifestyle intervention (own physician) — The experimental group will receive the video-based lifestyle intervention delivered by their own physician, while the control group will receive identical content delivered by physicians unknown to the participants. The intervention consists of structured multimedia modules focusing on nutrition, physical activity, strength exercise, and psychological strategies to support behavior change.
  • Behavioral: Video-based lifestyle intervention (unknown physician) — The experimental group will receive the video-based lifestyle intervention delivered by their own physician, while the control group will receive identical content delivered by physicians unknown to the participants. The intervention consists of structured multimedia modules focusing on nutrition, physical activity, strength exercise, and psychological strategies to support behavior change.
Study Locations (1 sites)
Juan Fco. Lisón. City: Valencia (Spain), Valencia, Spain
Eligibility Criteria
Inclusion Criteria: * Adults aged 18-65 years * Diagnosis of type 2 diabetes mellitus * Under medical follow-up in participating centers * Access to the internet and a smartphone * Ability to provide informed consent Exclusion Criteria: * Pregnancy * Type 1 diabetes or other specific forms of diabetes * Severe acute or unstable medical condition * Contraindication to diet or exercise * Severe psychiatric disorder * Eating disorder * Physical disability limiting physical activity * Participation in another structured weight-loss or lifestyle program * No medical visit in the last 2 years
Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity
NCT06335771
Recruiting
Conditions Obesity, Nonalcoholic Fatty Liver, Diabe...
Phase NA
Enrollment 60
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-10
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Study Details Design, interventions, and primary outcomes

About This Study

The goal of this study is to evaluate the role of transcription factor EB (TFEB) in adipose (fat) tissue macrophages (ATM) in regulating adipose tissue and systemic metabolic function in obesity. The investigators will assess the differences in ATM lipid metabolism in people with metabolically abnormal obesity and lean individuals. Both groups will have: * screening visit * imaging (body composition testing - dual-energy x-ray absorptiometry (DEXA) scans, magnetic resonance imaging \[MRI\] and magnetic resonance spectroscopy \[MRS\] scans) * Overnight visit with intravenous infusion (IV), muscle, and fat tissue biopsies Participants with obesity will complete meetings with study team members for a weight loss intervention to achieve a 10% body weight loss.

Design

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

Interventions / Regimen

  • Other: Dietary consultation weight loss intervention — Participants will meet with a member of the study team biweekly for about 6 months.

Primary Outcomes

  • Insulin sensitivity assessed as insulin-mediated glucose disposal during a hyperinsulinemic-euglycemic clamp procedure. (up to 6 months after the intervention)
  • 24-hour plasma glucose concentration (up to 6 months after the intervention)
  • Macrophage isolation in adipose tissue biopsy (up to 6 months after the intervention)
  • Macrophage isolation in skeletal muscle tissue (up to 6 months after the intervention)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-08-01
Completion: 2028-03
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 60 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Bettina Mittendorfer
Collaborators: National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Washington University School of Medicine
Principal Investigators:
  • Bettina Mittendorfer (PRINCIPAL_INVESTIGATOR) - University of Missouri-Columbia
Contact Information
Study Contact:
Heather McHatton
(573) 882-7619
heathermchatton@health.missouri.edu
Aman Pritish Aher
amanpritishaher@umsystem.edu
Interventions
  • Other: Dietary consultation weight loss intervention — Participants will meet with a member of the study team biweekly for about 6 months.
Study Locations (1 sites)
University of Missouri School of Medicine, Columbia, Missouri 65212 United States
Eligibility Criteria
Inclusion Criteria : * age: ≥18 but ≤70 years * not pregnant or breastfeeding * weight stable and sedentary before enrollment * no use tobacco products, excessive amounts of alcohol, or dietary supplements, or medications known to or suspected to affect glucose and lipid metabolism (aside from certain medications used to treat diabetes in the metabolically abnormal obesity \[MAO\]-Type 2 Diabetes group) * no evidence of significant organ system dysfunction or disease (e.g. chronic severe kidney disease, cancer) * participants must fulfil all of the following group-specific inclusion criteria below: Lean group: * Body mass index (BMI) ≥18.5 but \<25.0 kg/m2 * Intrahepatic triglyceride (IHTG) content \<5% * fasting blood glucose concentration: \<100 mg/dl * blood glucose concentration 2 h after a 75 g oral glucose challenge: \<140 mg/dl * Hemoglobin A1C (HbA1c) \<5.7 % Metabolically normal obesity (MNO) group: * BMI ≥30.0 but \<45.0 kg/m2 * IHTG content \<5% * fasting blood glucose concentration: \<100 mg/dl * blood glucose concentration 2 h after a 75 g oral glucose challenge: \<140 mg/dl * HbA1c \<5.7 % Metabolically abnormal obesity (MAO)-insulin resistance and non-alcoholic fatty liver disease (NAFLD) group: * BMI ≥30.0 but \<45.0 kg/m2 * IHTG content \>7.5% * fasting blood glucose concentration: ≥100 but \<126 mg/dl * blood glucose concentration 2 h after a 75 g oral glucose challenge: ≥140 but \<200 mg/dl * HbA1c: ≥5.7 but \<6.4 % MAO-type 2 diabetes group: * BMI ≥30.0 but \<45.0 kg/m2 * clinical diagnosis of type 2 diabetes or fasting blood glucose concentration \>126 mg/dl or blood glucose concentration 2 h after a 75 g oral glucose challenge\>200 mg/dl or HbA1c \>6.4 % without medication if not diagnosed and medically treated for diabetes Exclusion Criteria: \- Individuals that do not meet all inclusion Criterion
Manual Diaphragmatic Release Technique on Exercise Capacity and Sleep Quality
NCT06880783
Recruiting
Conditions Diabetes
Phase NA
Enrollment 44
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-10
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

To investigate if there is a significant effect of manual diaphragmatic release technique on exercise capacity, sleep quality, chest expansion, ADL, fatigue and quality of life in older adults with type II diabetes.

Design

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

Interventions / Regimen

  • Other: manual diaphragm release technique — The participant should be supine with relaxed limbs, and the therapist should position themselves at the head, making manual contact with the pisiform, hypothenar region, and fingers. The therapist should gently pull the contact towards the head, deepen it during exhalation, and gradually increase the depth.
  • Other: deep breathing exercises — Participants in a crook laying position are instructed to inhale through the nose, lift the abdomen, and let out through the mouth, breathing six breaths per minute for 30 minutes.

Primary Outcomes

  • 6-minute walk test (up to 6 weeks)
  • Pittsburgh Sleep Quality Index (PSQI) (up to 6 weeks)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-03-30
Completion: 2026-10
Eligibility
Age: 55 Years
Sex: ALL
Volunteers: false
Enrollment: 44 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Beni-Suef University
Contact Information
Study Contact:
Mohammed Yo Elhamrawy, Ph.D
+201282805567
dr_melhamrawy@yahoo.com
Interventions
  • Other: manual diaphragm release technique — The participant should be supine with relaxed limbs, and the therapist should position themselves at the head, making manual contact with the pisiform, hypothenar region, and fingers. The therapist should gently pull the contact towards the head, deepen it during exhalation, and gradually increase the depth.
  • Other: deep breathing exercises — Participants in a crook laying position are instructed to inhale through the nose, lift the abdomen, and let out through the mouth, breathing six breaths per minute for 30 minutes.
Study Locations (1 sites)
Beni suef hospital, Banī Suwayf, 62511 Egypt
Eligibility Criteria
Inclusion Criteria: * History of Diabetes Type II for more than one year. * They will be well controlled with HbA1c≤7. * Patients will be aged from 55 years and above and had a body mass index less than 30 kg/m². * Patients will follow up on the training program and instructions. They will be medically stable. Exclusion Criteria: * Chest diseases. * Diaphragmatic hernia, clinical evidence of phrenic nerve injury, recent abdominal or thoracic surgery, or history of traumatic lesion possibly affecting diaphragm. * History of Myocardial infarction and/or cardiothoracic surgery * Unstable medical status. * Cognitive disability hindering responding to the questionnaires.
AIRWEIGHS: Investigating Obesity as a Susceptibility Factor for Air Pollution in Childhood Asthma
NCT02763917
Active, positions filled
Conditions Asthma
Phase NA
Enrollment 198
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-09
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Background: Asthma and obesity are public health crises that have concurrently risen over the past decades, affecting millions of children in the United States and disproportionately affecting low-income minority children in urban areas. The same children at highest risk for asthma and obesity also have greater exposure to indoor and outdoor pollution. Emerging evidence suggests that obesity may confer increased susceptibility to health effects of air pollution. Methods: Aiming to provide causal-level evidence of these observational findings, we propose a home intervention study to 1) test whether targeted reductions of indoor Particulate Matter (PM) concentrations improve the respiratory health of overweight inner-city children with asthma more than that of lean inner-city children with asthma and 2) investigate mediators of susceptibility to indoor PM among overweight versus lean children with asthma. We will accomplish these aims using a 1:1 randomized controlled trial of 200 children with persistent asthma (half normal weight, half overweight) living in Baltimore City. Participants will be randomized to receive either two active air purifiers containing high-efficiency particulate air (HEPA) filters or two sham air purifiers with their filters removed. Implications: If the aforementioned observational findings are confirmed, implications will be directly relevant to the over 170 million children around the world now estimated to be overweight or obese.

Design

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

Interventions / Regimen

  • Device: Active Air Purifier — Two portable air purifiers containing HEPA filters will be placed in the bedroom and room where the participant reports spending the most time. Participants will be instructed to run the air purifiers continually. Participants will receive educational materials about environmental factors that are important for asthma health and environmental modification strategies, and educational materials about health benefits of maintaining a normal weight.
  • Device: Placebo Air Purifier — Homes in the control group will receive placebo air purifiers that have the internal air filters removed, but which will run normally. Participants will receive educational materials about environmental factors that are important for asthma health and environmental modification strategies, and educational materials about health benefits of maintaining a normal weight. At the end of the study, participants in the control group will receive active air purifiers. A control group is needed to ensure that reduced pollutant levels and health effects are not due to temporal trends and 'placebo effects' of being enrolled in an intervention trial. Participants will be informed that being in the study does not prevent them from purchasing and using air cleaners during the study period.

Primary Outcomes

  • Maximum Symptom Days (Baseline and about 12 weeks after the intervention)
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: 2016-08
Completion: 2027-09
Eligibility
Age: 8 Years
Sex: ALL
Volunteers: false
Enrollment: 198 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Johns Hopkins University
Collaborators: National Institute of Environmental Health Sciences (NIEHS)
Principal Investigators:
  • Meredith C. McCormack, MD, MHS (PRINCIPAL_INVESTIGATOR) - Johns Hopkins University, Pulmonary and Critical Care Medicine
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Device: Active Air Purifier — Two portable air purifiers containing HEPA filters will be placed in the bedroom and room where the participant reports spending the most time. Participants will be instructed to run the air purifiers continually. Participants will receive educational materials about environmental factors that are important for asthma health and environmental modification strategies, and educational materials about health benefits of maintaining a normal weight.
  • Device: Placebo Air Purifier — Homes in the control group will receive placebo air purifiers that have the internal air filters removed, but which will run normally. Participants will receive educational materials about environmental factors that are important for asthma health and environmental modification strategies, and educational materials about health benefits of maintaining a normal weight. At the end of the study, participants in the control group will receive active air purifiers. A control group is needed to ensure that reduced pollutant levels and health effects are not due to temporal trends and 'placebo effects' of being enrolled in an intervention trial. Participants will be informed that being in the study does not prevent them from purchasing and using air cleaners during the study period.
Study Locations (1 sites)
Meredith McCormack, Baltimore, Maryland 21224 United States
Eligibility Criteria
Inclusion Criteria: 1. 8-17 years of age 2. Persistent asthma (NAEPP criteria) 3. Exacerbation in previous 12 months 4. Non-smoker 5. Spends ≥4 nights/week at home 6. No plans to move during the study Exclusion Criteria: 1. Significant pulmonary or cardiac disease 2. Home not appropriate candidate due to disrepair 3. Underweight, defined by BMI \<5th percentile 4. Pregnancy
Body Composition Related Evaluation of Airway Tone and Hyper-rEactivity Using Oscillometry
NCT07356310
Recruiting
Conditions Breathing, Lung Function Decreased, Asth...
Phase Not Applicable
Enrollment 100
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-09
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This study will determine if airway resistance to airflow and pressure, measured by Oscillometry, is associated with abnormal findings on methacholine challenge testing and whether these findings are associated with body habitus,

Design

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

Interventions / Regimen

  • Device: Oscillometer — The tremoFlo C-100 Airwave Oscillometry System is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT).

Primary Outcomes

  • Oscillometer (Single measurement, approximately day 1)
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: 2026-02-17
Completion: 2027-11-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Rochester
Contact Information
Study Contact:
Patrick Donohue, MD
(585) 210-9301
patrick_donohue@urmc.rochester.edu
Interventions
  • Device: Oscillometer — The tremoFlo C-100 Airwave Oscillometry System is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT).
Study Locations (1 sites)
University of Rochester Medical Center, Rochester, New York 14620 United States
Eligibility Criteria
Inclusion Criteria: * Willingness to perform breathing test * Must be able to speak and understand English * Referred for Methacholine Challenge Test Exclusion Criteria: * Unable to provide consent or perform oscillometry test
Study of Indoor Air Pollutants and Their Impact in Childhood Health and Wellbeing
NCT05997784
Active, positions filled
Conditions Asthma in Children, Allergy
Phase Not Applicable
Enrollment 500
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-09
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The number and types of indoor air pollutants in schools is rising, however little is known about the impact of their potentially synergistic interactions, upon schoolchildren health. Among children, highly susceptible individuals to air pollution include allergy and asthma sufferers, and a low socioeconomic background, however no specific guidance is available. The Syn-Air-G project will develop a comprehensive and responsive multipollutant monitoring system (in accessible and actionable formats) by constructing and deploying novel but validated and improved sensors of chemical and biological (allergens, microbes) pollutants) and advancing environmentally friendly interventions (including air purifiers). Health: A comprehensive multidisciplinary and exposome approach of health effects of multi-pollution in small children.

Design

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

Interventions / Regimen

  • Other: Performing lung function tests (spirometry and fraction of exhaled nitric oxide (FeNO)) — Performing lung function tests and FeNO following European Respiratory Society (ERS) standardized guidelines, through the MIR portable spirometer and the NIOX Vero®, respectively. Spirometry is performed using a portable spirometer. All manoeuvres are performed according to the American Thoracic Society and European Respiratory Society (ATS/ERS) standards. FeNO test is a quick and non-invasive test that is easy for children to do. To take the test, the child have to blow into a handheld device (NIOX Vero®). More in detail, children are asked to inhale ambient air through a nitrogen oxide scrubber to total lung capacity, and then exhale for 10 seconds. The test results are available right away.
  • Other: Filling of standardized questionnaires — (Baseline, Follow-up, Quality of life and Final) allowing to collect data on sociodemographic characteristics, health outcomes, potential risk factors, lifestyle and living environment. Health outcomes will consider general health (general status, infections, allergies), respiratory health (asthma symptoms, diagnosis, control, triggers, medications, etc.), perception of health and well-being.
  • Other: Using an App on a device — Children will have to answer a daily questionnaire on cell phone, tablet, computer...), with the help of parents/caregivers. To encourage children to answer the questions, the questionnaires will be incorporated into a game that will also teach them about environmental challenges and pollutants in Europe. There will be a general health questionnaire with 3 questions assessed on a Likert scale. The application will also include 2 questions on respiratory health, with Yes/No answers. If the answer is Yes to one of the questions, the intensity of symptoms will be assessed on a visual analog scale from 0 to 100 (0 almost no symptoms and 100 the most intense symptoms imaginable).
  • Other: Urine sample — On a voluntary basis, a urine sample will be collected, as well.
  • Other: Sensors and devices will be used to assess air pollutants in classrooms during the survey — * Particulate matter (PM) will be assessed with a counter as a well as a remote sensor (Canarin) . * Volatile Organic Compound (VOCs) with a passive sampler (Radiello). * Virus and bacteria will be collected with a pump. The devices will be attached to the classroom wall. In addition, dust pollution will be assessed by collecting dust with a vacuum cleaner in order to assess phthalates (Dimethyl phthalate, diethyl phthalates, Di(2-ethylhexyl) phthalate).

Primary Outcomes

  • Indoor classroom air concentrations of Pollutants and dust (For 10 Months)
  • Prevalence for respiratory disease (For 10 Months)
  • Association between asthma and indoor air contaminants (For 10 Months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Active, positions filled
Start Date: 2025-01-30
Completion: 2028-09-01
Eligibility
Age: No restriction
Sex: ALL
Volunteers: true
Enrollment: 500 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University Hospital, Montpellier
Collaborators: National and Kapodistrian University of Athens, Tbilisi State Medical University, University of Manchester, University of Oulu
Principal Investigators:
  • Davide CAIMMI, CAIMMI (STUDY_DIRECTOR) - CHU de Montpellier
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Other: Performing lung function tests (spirometry and fraction of exhaled nitric oxide (FeNO)) — Performing lung function tests and FeNO following European Respiratory Society (ERS) standardized guidelines, through the MIR portable spirometer and the NIOX Vero®, respectively. Spirometry is performed using a portable spirometer. All manoeuvres are performed according to the American Thoracic Society and European Respiratory Society (ATS/ERS) standards. FeNO test is a quick and non-invasive test that is easy for children to do. To take the test, the child have to blow into a handheld device (NIOX Vero®). More in detail, children are asked to inhale ambient air through a nitrogen oxide scrubber to total lung capacity, and then exhale for 10 seconds. The test results are available right away.
  • Other: Filling of standardized questionnaires — (Baseline, Follow-up, Quality of life and Final) allowing to collect data on sociodemographic characteristics, health outcomes, potential risk factors, lifestyle and living environment. Health outcomes will consider general health (general status, infections, allergies), respiratory health (asthma symptoms, diagnosis, control, triggers, medications, etc.), perception of health and well-being.
  • Other: Using an App on a device — Children will have to answer a daily questionnaire on cell phone, tablet, computer...), with the help of parents/caregivers. To encourage children to answer the questions, the questionnaires will be incorporated into a game that will also teach them about environmental challenges and pollutants in Europe. There will be a general health questionnaire with 3 questions assessed on a Likert scale. The application will also include 2 questions on respiratory health, with Yes/No answers. If the answer is Yes to one of the questions, the intensity of symptoms will be assessed on a visual analog scale from 0 to 100 (0 almost no symptoms and 100 the most intense symptoms imaginable).
  • Other: Urine sample — On a voluntary basis, a urine sample will be collected, as well.
  • Other: Sensors and devices will be used to assess air pollutants in classrooms during the survey — * Particulate matter (PM) will be assessed with a counter as a well as a remote sensor (Canarin) . * Volatile Organic Compound (VOCs) with a passive sampler (Radiello). * Virus and bacteria will be collected with a pump. The devices will be attached to the classroom wall. In addition, dust pollution will be assessed by collecting dust with a vacuum cleaner in order to assess phthalates (Dimethyl phthalate, diethyl phthalates, Di(2-ethylhexyl) phthalate).
Study Locations (1 sites)
University Hospital of Montpellier, Montpellier, Occitanie 34295 France
Eligibility Criteria
Inclusion Criteria: * Child attending CM1 level at the beginning of the school year * Child in a classroom selected for the project * Child and caregiver(s) willing to follow the study procedures. Exclusion Criteria: Child or child's parents/guardian's who: * Refuse to participate to the project / to give informed consent * Do not want to use the application to fill the questionnaire and follow the protocol procedures. * Do not read or/and write in French * Plan a long stay outside the region that does not allow them to follow the visit plan
Vaginal Microbiome Exposure and Immune Responses in C-section Infants
NCT03567707
Active, positions filled
Conditions Allergic Diseases, Asthma
Phase EARLY_PHASE1
Enrollment 114
Locations 2 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-09-09
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The purpose of this research study is to assess at how differences in the microbiome (naturally occurring bacteria) of a baby may protect, or put a baby at risk, for allergic problems. The microbiome refers to the thousands of bacteria and molds that live in and on our bodies. The microbiome plays an important role in our health. Differences in the microbiome can affect our immune system in ways that might make some people more likely to get allergies and asthma. Early life events and exposures are very important for establishing the human microbiome. The newborn baby's microbiome changes very quickly during the first weeks and months of life. There is information that suggests C-section birth is associated with higher risk of certain diseases, including allergies and asthma. Some researchers think one reason for this is that passing through the mother's vaginal canal during birth exposes the baby to bacteria that promote healthy immune system development, something that C-section babies don't get. Transferring these potentially beneficial vaginal bacteria to C-section babies may help prevent some diseases later.

Design

Study type: Interventional Phases: Early Phase1 Allocation: Randomized Intervention model: Parallel Primary purpose: Prevention Masking/blinding: Triple

Interventions / Regimen

  • Drug: Vaginal seeding — Mother-infant pair randomized to vaginal microbiota intervention. As soon as the infant is delivered, the infant will be brought to the neonate lamp, and unless the obstetrician or pediatric staff believes it is not in the best interest of the infant, s/he will be swabbed with the vaginal microbiota soaked gauze. Swabbing will take place ideally within 1 minute after delivery (but no longer than 5 minutes). The swabbing should take approximately 15 seconds. Infants will only undergo the seeding procedure once.
  • Drug: Placebo Seeding — Mother-infant pair randomized to placebo microbiota intervention. As soon as the infant is delivered, the infant will be brought to the neonate lamp, and unless the obstetrician or pediatric staff believes it is not in the best interest of the infant, s/he will be swabbed with the placebo gauze. Swabbing will take place ideally within 1 minute after delivery (but no longer than 5 minutes). The swabbing should take approximately 15 seconds. Infants will only undergo the seeding procedure once.
  • Other: Standard care — Mother-infant pair, with both receiving standard of care which includes standard physical exams, vital signs monitoring and medication administration given as standard care for the delivery
  • Other: Post-seeding Care — Following the seeding procedure, infants will then receive the standard detailed examination for newborns and standard of care, except that the first infant bath will occur at least 12 hours after delivery.

Primary Outcomes

  • Presence of Sensitization to at Least One Food Allergen at 12 months of age - by Treatment Group (Infants at 12 months of age (=Month 12 visit))
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: Active, positions filled
Start Date: 2018-11-28
Completion: 2027-01
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 114 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: Immune Tolerance Network (ITN), PPD Development, LP, Rho Federal Systems Division, Inc.
Principal Investigators:
  • Hugh A. Sampson, MD (STUDY_CHAIR) - Icahn School of Medicine at Mount Sinai
  • Jose C. Clemente, PhD (STUDY_CHAIR) - Icahn Institute for Genomics & Multiscale Biology
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Drug: Vaginal seeding — Mother-infant pair randomized to vaginal microbiota intervention. As soon as the infant is delivered, the infant will be brought to the neonate lamp, and unless the obstetrician or pediatric staff believes it is not in the best interest of the infant, s/he will be swabbed with the vaginal microbiota soaked gauze. Swabbing will take place ideally within 1 minute after delivery (but no longer than 5 minutes). The swabbing should take approximately 15 seconds. Infants will only undergo the seeding procedure once.
  • Drug: Placebo Seeding — Mother-infant pair randomized to placebo microbiota intervention. As soon as the infant is delivered, the infant will be brought to the neonate lamp, and unless the obstetrician or pediatric staff believes it is not in the best interest of the infant, s/he will be swabbed with the placebo gauze. Swabbing will take place ideally within 1 minute after delivery (but no longer than 5 minutes). The swabbing should take approximately 15 seconds. Infants will only undergo the seeding procedure once.
  • Other: Standard care — Mother-infant pair, with both receiving standard of care which includes standard physical exams, vital signs monitoring and medication administration given as standard care for the delivery
  • Other: Post-seeding Care — Following the seeding procedure, infants will then receive the standard detailed examination for newborns and standard of care, except that the first infant bath will occur at least 12 hours after delivery.
Study Locations (2 sites)
Mount Sinai West, New York, New York 10019 United States
Icahn School of Medicine at Mount Sinai, New York, New York 10029 United States
Eligibility Criteria
Inclusion Criteria: * Pregnant woman must be able to understand and provide informed consent; * Pregnant women with singleton pregnancies with a non-anomalous, appropriately-grown fetus; and * Atopic disease (asthma, allergic rhinoconjunctivitis, or atopic dermatitis) or food allergy in a first-degree relative of the infant to-be-delivered (for exception, see exclusion criteria\*). Exclusion Criteria: For C-Section Mothers: * In labor with evidence of cervical change prior to the scheduled C-section; * Rupture of the amniotic sac; or * Vaginal pH \> 4.5 on the day of delivery. For Vaginal Delivery Mothers: \- Use of induction agents for cervical ripening (cervical prostaglandin or Foley catheter). For All Mothers and Their Infants: * Inability or unwillingness of a participant to give written informed consent or comply with study protocol; * History of moderate to severe atopic dermatitis within the past year in the mother; * Express no intention to breastfeed; * History of diabetes mellitus or gestational diabetes mellitus; * History of inflammatory bowel disease (IBD) (e.g., Crohn's Disease or ulcerative colitis); * Evidence of an active sexually transmitted infection (STI) (e.g., primary herpes or genital warts, or trichomonas), yeast infection, or vaginosis on the day of delivery; * Evidence of prior or current hepatitis B or C infection as demonstrated by the presence of the hepatitis B surface antigen, antibody positivity against the hepatitis B core antigen, or antibody positivity against the hepatitis C virus; --Assessment for active hepatitis B and hepatitis C infection will be repeated for this study even if prior testing during the current pregnancy was negative; * Evidence of Human Immunodeficiency Virus (HIV) infection (e.g., positive HIV serology or detectable viral load); * Positive Group B Streptococcus (GBS) test results by rectovaginal swab performed within 5 weeks of delivery, a prior infant with invasive GBS disease, or GBS bacteriuria at any point during pregnancy; * Evidence of N. gonorrhoeae or C. trachomatis infection by testing performed within 5 weeks of delivery; * History of antibiotic administration during the third trimester of the current pregnancy; * Mothers with serious chronic conditions during pregnancy; * Mothers with complicated pregnancies including pre-eclampsia, chorioamnionitis, placenta previa, vasa previa, placental abruption, or active vaginal bleeding; * Maternal fever on the day of delivery (visit 0); * Infants with complications during delivery, such that the infant requires more than the standard neonatal resuscitation after delivery; * Infants delivered prior to 37 weeks of gestation; * Thick particulate meconium noted upon delivery of the infant; * Presence of a congenital abnormality in the infant for which study participation is not recommended; * Current, diagnosed mental illness or current, diagnosed or self-reported drug or alcohol abuse in the mother that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements; * Use of investigational drugs during the third trimester of pregnancy; or * Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator may: * Pose additional risks from participation in the study, * Interfere with the participant's ability to comply with study requirements, or * May impact the quality or interpretation of the data obtained from the study.
A Randomized, Double-Blind, Placebo-Controlled Trial on Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate Combination in Participants 12 Years and Older With Asthma
NCT06664619
Recruiting
Conditions Asthma
Phase PHASE3
Enrollment 724
Locations 189 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-09-09
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The primary objective of the trial is to evaluate the efficacy of fluticasone propionate/albuterol sulfate multidose dry powder inhaler with electronic module (Fp/ABS eMDPI). Secondary objectives are: * To evaluate the efficacy of Fp/ABS eMDPI administered four times daily * To evaluate the safety and tolerability of Fp/ABS eMDPI administered four times daily over four weeks * To investigate the pharmacokinetics of Fp/ABS eMDPI, ABS eMDPI and Fp eMDPI after administration of a single dose The planned study duration for each participant is approximately 10 weeks, excluding an optional prescreening visit.

Design

Study type: Interventional Phases: Phase3 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Quadruple

Interventions / Regimen

  • Drug: Fp/ABS — Inhalation powder
  • Drug: FP — Inhalation powder
  • Drug: ABS — Inhalation powder
  • Drug: Placebo — Inhalation powder

Primary Outcomes

  • Change from Baseline forced expiratory volume in one second (FEV1) area under the effect curve over 4 weeks (Baseline, Week 4)
  • Change from Baseline trough FEV1 at week 4 (Baseline, Week 4)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Recruiting
Start Date: 2024-12-12
Completion: 2026-09-19
Eligibility
Age: 12 Years
Sex: ALL
Volunteers: false
Enrollment: 724 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Teva Branded Pharmaceutical Products R&D LLC
Principal Investigators:
  • Teva Medical Expert, MD (STUDY_DIRECTOR) - Teva Branded Pharmaceutical Products R&D LLC
Contact Information
Study Contact:
Teva U.S. Medical Information
1-888-483-8279
USMedInfo@tevapharm.com
Interventions
  • Drug: Fp/ABS — Inhalation powder
  • Drug: FP — Inhalation powder
  • Drug: ABS — Inhalation powder
  • Drug: Placebo — Inhalation powder
Study Locations (189 sites)
Teva Investigational Site 12087, Phoenix, Arizona 85015 United States
Teva Investigational Site 12144, Phoenix, Arizona 85020 United States
Teva Investigational Site 12104, Tucson, Arizona 85715 United States
Teva Investigational Site 12146, Tucson, Arizona 85741 United States
Teva Investigational Site 12102, Little Rock, Arkansas 72205 United States
Teva Investigational Site 12154, Encinitas, California 92024-2812 United States
Teva Investigational Site 12103, Huntington Beach, California 92647 United States
Teva Investigational Site 12068, La Palma, California 90623 United States
Teva Investigational Site 12152, Laguna Niguel, California 92677 United States
Teva Investigational Site 12145, Long Beach, California 90815 United States
Eligibility Criteria
Inclusion Criteria: * The participant has a diagnosis of asthma of at least 6 months duration. * Participants currently receive a beta-agonist (eg, salbutamol \[albuterol\] or ICS albuterol or ICS-formoterol) as rescue medication with or without asthma controller medication. * If female, a participant is currently not pregnant, breastfeeding, or attempting to become pregnant (for at least 30 days before the screening visit and throughout the duration of the trial), or is of non-childbearing potential. NOTE- Additional criteria apply, please contact the investigator for more information Exclusion Criteria: * The participant has a history of life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation, associated with hypercapnia, respiratory arrest, hypoxic seizures or an asthma related syncopal episode. * The participant has had an upper or lower respiratory tract infection within 2 weeks or has had a confirmed case of COVID-19 within 6 weeks prior to Visit 1. Symptoms of the infection(s) must be completely resolved prior to entering screening. * The participant is a current smoker and/or has a history of ≥10 pack years history of smoking. A current smoker is defined as any participant who has used any form of tobacco product (including oral) within the past 6 months, or any orally inhaled products including but not limited to cigarettes, beedis, vaping/ e-cigarettes, hookah/waterpipes, or marijuana. Note: participants with a positive urinary cotinine test will be excluded. * The participant has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, pulmonary fibrosis), or participants with a diagnosis of asthma COPD overlap syndrome. NOTE- Additional criteria apply, please contact the investigator for more information
A Phase 1 Trial of AMG 691 in Healthy Chinese and Japanese Volunteers
NCT07745907
Recruiting
Conditions Healthy Participants
Phase PHASE1
Enrollment 28
Locations 1 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-09-09
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The trial is designed to evaluate the pharmacokinetics, safety, tolerability, and immunogenicity of AMG 691 in healthy Chinese and Japanese participants

Design

Study type: Interventional Phases: Phase1 Allocation: Randomized Intervention model: Parallel Primary purpose: Basic Science Masking/blinding: None

Interventions / Regimen

  • Drug: AMG 691 — AMG 691 will be administered subcutaneously

Primary Outcomes

  • Maximum Observed Serum Concentration (Cmax) of AMG 691 (Day 1 up to Day 154)
  • Area Under the Serum Concentration Time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of AMG 691 (Up to Day 154)
  • Area Under the Serum concentration Time Curve from Time Zero to Infinity (AUC0-inf) of AMG 691 (Up to Day 154)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Recruiting
Start Date: 2026-08-07
Completion: 2027-03-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 28 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Amgen
Principal Investigators:
  • MD (STUDY_DIRECTOR) - Amgen
Contact Information
Study Contact:
Amgen Call Center
866-572-6436
medinfo@amgen.com
Interventions
  • Drug: AMG 691 — AMG 691 will be administered subcutaneously
Study Locations (1 sites)
PPD - Las Vegas Research Unit, Las Vegas, Nevada 89113 United States
Eligibility Criteria
Inclusion Criteria: * Healthy male or female participants, 18 to 60 years of age. * First-generation Chinese ancestry (born in China, Hong Kong, Taiwan, or Macau with 2 Chinese parents and 4 Chinese grandparents) or first-generation Japanese ancestry (born in Japan with 2 Japanese parents and 4 Japanese grandparents). * Body mass index (BMI) 18.0 to 30.0 kg/m\^2 (inclusive) and body weight ≥40 kg. * In good general health based on medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory evaluations. * Female participants must not be pregnant or breastfeeding. * Participants of reproductive potential must agree to follow protocol-specified contraception requirements. * Willing to maintain usual diet and physical activity regimen throughout study participation. Exclusion Criteria: * Clinically significant medical condition, disease, or abnormal finding that could interfere with study participation or interpretation of results. * Clinically significant ECG abnormalities * Clinically significant abnormal blood pressure or pulse rate at screening/check-in. * History of malignancy (except adequately treated in situ cervical cancer or non-melanoma skin cancer \>5 years before dosing). * Deep vein thrombosis or pulmonary embolism within 3 months prior to check-in. * History of hypersensitivity/anaphylaxis to biologic therapies, mammalian-derived products, or AMG 691 excipients. * Active, chronic, recurrent, or unresolved infection; history of severe infection requiring intravenous (IV) antibiotics within the past 3 years. * Positive or indeterminate QuantiFERON-TB Gold test. * Untreated or unresolved helminth parasitic infection. * History of immunodeficiency. * Receipt of live or live-attenuated vaccines within 12 weeks before check-in or planned during the study. * Estimated glomerular filtration rate (eGFR) \<70 mL/min/1.73 m\^2. * Alanine Aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, or direct bilirubin \>1.5 × Upper Limit Normal (ULN). * Positive screening tests for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection. * Use of prohibited prescription, over-the-counter, herbal, vitamin, or dietary supplement products within 30 days (or 5 half-lives) before enrollment, unless approved by the investigator. * History of illicit drug use within 1 year, positive drug screen, or unwillingness to abstain from illicit drugs/cannabinoids during the study. * Use of tobacco or nicotine-containing products within 6 months prior to check-in. * History of alcohol abuse or excessive alcohol consumption. * History of non-suicidal self-injury within 5 years or unstable major depressive disorder/other severe psychiatric disorder within 2 years. * Participation in another investigational drug study within 90 days (or 5 half-lives) prior to check-in. * Previous exposure to AMG 691. * Recent donation of blood, plasma, or platelets. * Any participant considered unsuitable by the investigator or unwilling to comply with study restrictions.