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About This Study

The growing U.S. cancer survivor population is projected to hit 26M by 2040. Chemotherapy represents an effective cancer treatment but can diminish cancer survivors' quality of life-particularly cognitive function-through select pathophysiological processes. Research on chemotherapy-induced cognitive impairment (hereafter, 'chemo-brain') is therefore critical. Chemotherapy disrupts immune system function and antioxidant regulation, causing inflammatory molecule release and damaging the brain's blood vessels. The brain's vascular function and, possibly, its neurons, are subsequently impaired-likely contributing to chemo-brain. Type 2 diabetes (T2D), a common cancer survivor comorbidity, shares underlying pathophysiology with chemo-brain. T2D-related insulin resistance can precipitate repeated high blood sugar episodes which increase inflammatory molecule release. In individuals with T2D without cancer, negative relationships are observed between inflammatory molecule concentrations and the brain's vascular and/or cognitive function. Cancer survivors with T2D might thus have higher chemo-brain risk than those without T2D. Yet, more research must compare how the brain's vascular function, as well as cognitive, inflammatory, and cardiometabolic indices, differ between these groups. Physical activity (PA) counteracts chemo-brain's and T2D's pathophysiology, with higher PA/fitness resulting in better vascular function of the brain, lower inflammatory molecule concentrations, and improved insulin sensitivity. We are therefore conducting a 30-participant quasi-experimental pilot study in cancer survivors with (cases) and without (controls) T2D. We will first investigate between-group differences in the brain's vascular function as well as cognitive, inflammatory, cardiometabolic, and epigenetic outcomes. We will then examine between-group changes in these outcomes and select psychosocial metrics during a 12-week technology-based PA program-potentially further elucidating involved mechanisms.

Design

Interventions / Regimen

• Behavioral: Social Cognitive Theory-based, Technology-delivered Physical Activity Program — Participants will engage in a 12-week program of aerobic and muscle-strengthening physical activity. This program will be delivered remotely via two smartphone applications--one for providing health education, goal setting, and journaling features and the other for delivery of the physical activity program in a highly-personalized and HIPAA-compliant manner. Participants will receive a Fitbit to track their activity and resistance bands to use during their resistance training physical activity. All program components will be based in the Social Cognitive Theory and will target improving participants' physiological and psychological health outcomes.

Primary Outcomes

• Middle Cerebral Artery Velocity (Baseline and After Study Week 12)
• Cerebrovascular Resistance (Baseline and After Study Week 12)
• Cerebrovascular Conductance (Baseline and After Study Week 12)
• Cerebrovascular Pulsatility (Baseline and After Study Week 12)
• Dynamic Cerebral Autoregulation (Baseline and After Study Week 12)
• Cognitive Function (Baseline and After Study Week 12)

About This Study

Diabetes mellitus (DM) is an epidemic disease, with approximately 463 million persons diagnosed with it. Of those, 90% are patients with type 2 DM (T2DM). Some estimates indicate that 700 million cases of DM will be reported in 2045. T2DM develops due to insulin resistance, leading to reduced insulin secretion. DM has a number of associated complications, such as nephropathy, neuropathy, and cardiovascular disease.

Design

Interventions / Regimen

• Diagnostic Test: Glycated hemoglobin (HbA1C) — Blood test will be done at time of recruitment (for 2 groups) , after 3 months and after 6 months (for group 1 )
• Diagnostic Test: RDW — Blood test will be done at time of recruitment (for 2 groups) , after 3 months and after 6 months (for group 1 )
• Diagnostic Test: Lipid profile — Blood test will be done at time of recruitment (for 2 groups) , after 3 months and after 6 months (for group 1 )

Primary Outcomes

• To assess the correlation between RDW and HbA1C levels in patients with T2DM before and after glycemic control. ("At time of inclusion in the study", "3 months", "6 months")

About This Study

Type 2 diabetes (T2D), especially when associated with metabolic syndrome (MS) is at high risk to develop heart failure with preserved ejection fraction (HFpEF) or heart failure with mildly reduced ejection fraction (HFmrEF), and the specific impact of T2D+MS in cardiac function impairment is usually known as "diabetic cardiomyopathy" (DC). Cardiac remodelling (ie hypertrophy) and subtle myocardial dysfunction are highly prevalent in T2D+MS but not specific enough to predict further HFpEF or HFmrEF. Also, current biomarkers can identify but do not predict HFpEF or HFmrEF in T2D patients; Furthermore, specific biomarkers are needed. Peripheral blood mononuclear cells (PBMC) obtained from a peripheral blood sample can provide insights from calcic and inflammatory pathways, and may identify more specific molecular signatures shared between T2D+MS and HFpEF.

Design

Interventions / Regimen

• Biological: Blood test — During the routine blood test of the patient, 4 more tubes of 4 milliliters (mL) will be collected to make a biological collection of PBMC and plasma for further analysis.
• Behavioral: quality of life Questionnaire — During the routine medical visit, the patient will be asked to fill in a short questionnaire about quality of life. This is a descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. This decision results into a 1-digit number that expresses the level selected for that dimension. Each patient's health state is referred to in terms of a 5-digit code; Levels of perceived problems are coded as follows: * Level 1 is coded as a '1' (indicating no problem) * Level 2 is coded as a '2' (indicating some problems) * Level 3 is coded as a '3' (indicating extreme problems) For example, state 11223 indicates no problems with mobility and self-care, no problems with performing usual activities, moderate pain or discomfort and extreme anxiety or depression, while state 11111 indicates no problems.
• Behavioral: Diet habits questionnaire — During the routine medical visit, the patient will be asked to fill in a short questionnaire about his diet habits. This is an exploratory questionnaire that describes and quantifies the foods (pro- or anti-inflammatory) ingested by patients.

Primary Outcomes

• Comparison of Initial level of Ca2+ fluxes from T2D+MS patients vs non T2D+MS patients, according to the presence or not of HFpEF or HFmrEF (Day of blood sample (inclusion visit))
• Comparison of amplitude of Ca2+ fluxes from T2D+MS patients vs non T2D+MS patients, according to the presence or not of HFpEF or HFmrEF (Day of blood sample (inclusion visit))
• Comparison of area under curve of Ca2+ fluxes from T2D+MS patients vs non T2D+MS patients, according to the presence or not of HFpEF or HFmrEF (Day of blood sample (inclusion visit))
• Comparison of slope of the response to pharmacological stimulation of Ca2+ fluxes from T2D+MS patients vs non T2D+MS patients, according to the presence or not of HFpEF or HFmrEF (Day of blood sample (inclusion visit))
• Comparison of the inflammatory profile of PBMC from T2D+MS patients vs non T2D+MS patients, according to the presence or not of HFpEF or HFmrEF (Day of blood sample (inclusion visit))

About This Study

The present 24-week, prospective, open-label, randomized, multicenter, parallel group trial is carried to investigate and evaluate the efficacy and safety of Liraglutide in combination with prandial insulin therapy vs insulin glargine in combination with prandial insulin therapy in overweight / obese patients with uncontrolled type 2 diabetes.

Design

Interventions / Regimen

• Drug: Liraglutide — Patients will receive adding Liraglutide to prandial insulin Lispro. The starting liraglutide dose was 0.6mg/day, then 1.2mg/day after 1 week and 1.8mg/day after a further week. The dose was maintained until study completion. Dose of insulin Lispro will be instructed on a titration schedule, adjusted every 3 days.
• Drug: insulin glargine — Individuals randomized to adding insulin Glargine to prandial insulin Lispro will be instructed on a titration schedule, adjusted every 3 days. Patients subcutaneously self-injected once-daily at approximately the same time each day.

Primary Outcomes

• the proportion of patients with HbA1c < 7.0% without experiencing hypoglycemia and without weight gain,with a superiority margin of 3% (24 weeks)

About This Study

The prevalence of cognitive dysfunction in diabetic patients is high, which seriously affects the quality of life of patients, and early intervention is of great significance. Central nervous system insulin resistance plays a key role in the pathogenesis of cognitive dysfunction in diabetic patients. Central insulin resistance observed by functional magnetic resonance imaging (fMRI), may serve as an alternative endpoint for assessing cognitive function. Sodium glucose cotransporter 2 inhibitor (SGLT2i) may improve cognitive impairment by improving central insulin resistance.

Design

Interventions / Regimen

• Drug: Canagliflozin group — Canagliflozin,100mg once daily, orally, for 6 months
• Drug: Sitagliptin — Sitagliptin,100mg once daily, orally, for 6 months
• Drug: Acarbose — Acarbose,100mg three times daily, orally, for 6 months

Primary Outcomes

• the changes in cerebral blood flow shown by fMRI (6 months)

About This Study

Recent research has highlighted the significant relationship between type 2 diabetes mellitus and cancer, both prevalent and impactful on global health. The intrinsic correlation arises from shared metabolic processes, particularly a systemic and chronic inflammatory state driven by factors like obesity, dyslipidemia, and hyperglycemia. This leads to the creation of a self-sustaining microenvironment known as meta-inflammation, promoting cancer development through DNA damage, oxidative stress, and the influence of hormones like leptin. The hyperglycemic environment in diabetes contributes to cancer development, supporting the Warburg effect and insulin-related mechanisms. This study aims to identify risk factors associated with diabetes that impact tumor development and progression, crucial for guiding effective preventive strategies in clinical practice. Primary objective of the study: \- identify the risk factors affecting the occurrence of cancer in the population affected by type 2 diabetes mellitus; Secondary objectives of the study: * description of the demographic, clinical and first-line therapy characteristics of patients diagnosed with type 2 diabetes mellitus; * assess risk factors for recurrence, presence of a second tumour not related to the first and the presence of both events in patients who have had a tumor within 10 years of diagnosis of diabetes; * assess the relationship between the characteristics of patients and the time to the onset of cancer.

Design

Interventions / Regimen

• Other: phenotyping of patients followed at a third-level diabetes centre with cancer — Collection of the following data for each patient enrolled, where possible: * Gender and age; * Smoking habits and alcohol consumption (units per day); * Weight and body mass index (BMI) at first (T0) and last visit (T1); * Given by the diagnosis of type 2 diabetes mellitus; * Treatment of type 2 diabetes at T0 and T1; * Levels of glycated hemoglobin (hba1c) at T0 and T1, mean hba1c and mean fasting blood sugar; * Creatinine clearance at T0 and T1; * Liver enzymes at T0 and T1: alanine aminotransferase (ALT) and aspartate aminotransferase (AST); * T0 and T1 lipid profile: low density lipoproteins (LDL-c) and triglycerides (TG); * Complications of type 2 diabetes; * Treatment of cancer; * Family history of cancer.

Primary Outcomes

• Smoking assessment at first visit (Assessment of data at time 0 (first clinical visit))
• Alcool consumption at first visit (Assessment of data at time 0 (first clinical visit))
• BMI assessment at first visit (Assessment of data at time 0 (first clinical visit))
• Glycated assessment at first visit (Assessment of data at time 0 (first clinical visit))

About This Study

Type 2 diabetes is a growing health concern worldwide, influenced by genetic factors, overweight, metabolic syndrome, and insufficient physical activity. Good treatment and glycemic control can reduce or delay diabetes-related complications, which account for a significant and increasing share of healthcare costs in Finland. Much of this cost growth is due to complications resulting from inadequate diabetes care. Secondary prevention programs can therefore provide both health and economic benefits. Lifestyle interventions are one way to improve type 2 diabetes care and reduce complications. This study aims to evaluate the impact of a digital lifestyle intervention combined with optimized care on treatment and outcomes among adults with type 2 diabetes at high risk for complications. The intervention includes access to the BitHabit "Small Actions" application, which supports healthy lifestyle changes, and for participants with a body mass index (BMI) over 30, the Onnikka weight management application. The study will be conducted in North Savo, Finland, using a case-control design. Approximately 120 participants will receive the intervention and 50-100 will serve as controls. All participants will have their care plans reviewed and updated according to the Finnish Current Care Guidelines for Type 2 Diabetes. Control group participants will receive standard care, while the intervention group will receive standard care plus the digital tools. The study also includes the validation of the PAID (Problem Areas in Diabetes) questionnaire for use in Finland and in the Finnish language. The study duration for each participant is 12 months. Data will be collected through physiological measurements, laboratory tests, questionnaires, and app usage logs. Measurements and questionnaires will be conducted at baseline and after 12 months. The analyses will describe the phenomenon, its prevalence, and associations between variables, as well as potential dependencies.

Design

Interventions / Regimen

• Other: BitHabit digital application for behavioral lifestyle changes — BitHabit digital application for behavioral lifestyle changes
• Other: Onnikka weight management digital application — Onnikka weight management digital application

Primary Outcomes

• Change from baseline in weight at 12 months (From enrollment to the end of follow-up at 12 months)
• Change from baseline in BMI at 12 months (From enrollment to the end of follow-up at 12 months)
• Change from baseline in waist circumference at 12 months (From enrollment to the end of follow-up at 12 months)
• Change from baseline in Body Roundness Index at 12 months (From enrollment to the end of follow-up at 12 months)
• Change from baseline in HbA1c at 12 months (From enrollment to the end of follow-up at 12 months)
• Change from baseline in serum lipid levels at 12 months (From enrollment to the end of follow-up at 12 months)
• Change from baseline in smoking status at 12 months (From enrollment to the end of follow-up at 12 months)
• Change from baseline in physical activity at 12 months (From enrollment to the end of follow-up at 12 months)

About This Study

Adolescents and young adults (AYA) with type 2 diabetes (T2D) have a more severe phenotype than what is seen in youth-onset type 1 diabetes or adult-onset T2D including earlier kidney and cardiovascular disease complications; and prioritizing new treatments, either for standalone use or in combination with other therapies is critical. T2D triggers the release of proinflammatory mediators called cysteinyl leukotrienes leading to damage to the kidneys and blood vessels. This clinical trial will evaluate the effects of montelukast, a cysteinyl leukotriene inhibitor, on kidney and vascular function in AYA with T2D to help direct future diabetes care to limit diabetic kidney and cardiovascular disease complications.

Design

Interventions / Regimen

• Drug: Montelukast — montelukast 10 mg daily for patients aged 15 and older, 5 mg daily for patients aged 14
• Drug: Montelukast Placebo — one microcrystalline cellulose tablet daily

Primary Outcomes

• Change in renal vascular resistance (RVR) (0 and 6 months)

About This Study

This study will examine changes in ankle muscle activity and functional performance following whole-body vibration training in women with obesity, with and without type 2 diabetes. It will also compare the responses to training between these two groups. Participants will attend supervised training twice a week for eight weeks. During training, they will perform exercises on a platform that produces mechanical vibrations. The exercises will progress gradually and will be adapted to each participant's abilities and tolerance. Each session will include warm-up and cool-down exercises. Before and after the training program, researchers will assess muscle activity during normal walking, heel-to-toe walking, and standing with one foot directly in front of the other. Small sensors placed on the skin will record activity from three muscles around each ankle. Walking and functional performance will also be assessed. The study aims to help researchers understand whether women with obesity with and without type 2 diabetes show different changes in muscle activity and functional performance after the same training program.

Design

Interventions / Regimen

• Device: Whole-Body Vibration Training — Supervised whole-body vibration training will be delivered using a Hypervibe G14 Home V3 side-alternating platform twice weekly for eight weeks (16 sessions). The program comprises three stages: weeks 1-2, 3-5, and 6-8. Exercise-specific frequencies range from 6 to 30 Hz. Planned active vibration exposure per session is 12 minutes, 10.5 minutes, and 15.5 minutes across the three stages, respectively. Sessions include a 5-minute walking warm-up, platform-based exercises and vibration massage, followed by mat-based cool-down exercises. Exercise position, range of motion, support, duration, and rest will be adapted to participant tolerance within protocol limits. Borg 6-20 ratings will be recorded after each session, with a target perceived exertion of 12-14 guiding subsequent adjustments. Both groups will receive the same protocol.

Primary Outcomes

• Change in Tibialis Anterior Muscle Activation (Baseline and after completion of the 8-week intervention)
• Change in Soleus Muscle Activation (Baseline and after completion of the 8-week intervention)
• Change in Medial Gastrocnemius Muscle Activation (Baseline and after completion of the 8-week intervention)

About This Study

Primary aim: To investigate if app-based education and training of inhalation technique improves the rate of successful inhalation techniques compared with control group at 6-12 weeks follow-up visit. Secondary aims: To evaluate the feasibility, usability, and safety of the investigational during the study period. Study design: Two-armed, parallel-designed, individual single-blinded stratified randomisation by inhaler (DPI/MDI/both DPI and MDI) controlled trial with assignment (1:1) to (1) standard care and app-based education and training of inhalation technique or (2) standard education of inhalation technique over 6-12 weeks. Subjects: Subjects from the age of 16 years with documented diagnosis of asthma and/or COPD, daily treated with dry powder inhaler (DPI) or metered dose inhaler (MDI), or both, will be invited to voluntarily participate. Exclusion criteria is age \<16 years, no access to use BankID or similar electronic personal identification service, not using smartphone of type Android or iPhone, plan to stop use DPI and/or MDI the following 6-12 weeks from inclusion. No able to independently handle and inhale through DPI or MDI device. Total sample size: Eighty subjects (females and males) with daily treatment for COPD or asthma will be sufficient, based on the assumption of 25% percentage improvement in success rate of correct inhalation technique in the interventional group compared with control group (75% versus 50%) with 80% power at 5% significance level, including dropouts at 6-12 weeks follow-up visit. Intervention: At the baseline visit patients will be randomised to app-based intervention consisting of education and training of inhalation technique of all inhalers used on daily basis (the inhalation app-module). Stratified randomisation based on type of inhaler(s); MDI, DPI or both MDI and DPI will be applied. The intervention is the inhalation app-module, which is a medical device that is embedded the AsthmaTuner app. The AsthmaTuner app is a CE-marked cloud-based system (MDR Class 2b), provided by MediTuner AB, Stockholm, Sweden. The intervention group will be instructed to use the inhalation app-module on daily basis to improve their inhalation technique. Control group: Standard education of inhalation technique using list of standardised criteria and non-app-based education of inhaler technique. Endpoints: Primary endpoint is the rate of subjects with successful inhalation techniques based on subjective critical endpoints (CIP Table 2) and the following objective endpoints at the 6-12 weeks follow up visit: * DPI: PIF \> 30 L/Min, time to PIF \<0.5 seconds measured with the investigational device. * MDI: inspiration time (\> 3 seconds) and PIF less than 60 L/Min measured with the investigational device. Procedures: At baseline, a trained respiratory nurse will subjectively assess and train each patient's inhalation technique according to defined criteria of device handling (standard education). The AsthmaTuner…

Design

Interventions / Regimen

• Device: App-based education and training of inhalation technique — The inhalation flow is measured by the wireless spirometer (MIR AsthmaTuner), using connecter (Airflow Trainer) for creating inspiratory flow resistance .(adjustable resistance). The inhalation module starts with patients selecting their inhaler type (DPI or MDI). This leads to written instructions which show patients how they should inhale their medication. The patient is then forwarded to the training part of the module, which allows a patient to inhale through their spirometer which is fitted with the Airflow Trainer (MIR). The patient will be able to see how their inhalation went and will pass or fail the training. The app-based investigational device provides educational materials for patients on how to successfully use the inhaler.

Primary Outcomes

• Primary endpoint is number of subjects presenting successful inhalation techniques. (6-12-week follow-up visit)

About This Study

The main purpose of this Phase 2 double blind, placebo controlled crossover clinical study is to demonstrate the efficacy and safety of CXA-10 in obese adult asthmatics. Obesity induces a chronic systemic inflammatory state characterized by impaired adipokine signaling, pro-inflammatory cytokine responses, inflammatory cell activation and enhanced generation of oxidative inflammatory mediators. This impacts the lung, increasing the severity of asthma and its exacerbations. This research will evaluate how a synthetic nitro-fatty acid (CXA-10, 10-nitro-octadec-9-enoic acid) suppresses the systemic and airway inflammation that contributes to the obese asthmatic phenotype. Current data support the pleiotropic signaling actions of CXA-10 to induce adaptive signaling actions that beneficially modulate adipokine and cytokine expression and inhibit systemic and pulmonary inflammation. The investigators hypothesize that CXA-10 induced signaling responses will alleviate obesity-related airway hyperreactivity in obese adult asthmatics.

Design

Interventions / Regimen

• Drug: CXA-10 — 6 weeks of treatment with 150 mg/day of orally administered CXA-10
• Drug: Matching Placebo — 6 weeks of treatment with orally administered matching placebo (to 150 mg/day of CXA-10)

Primary Outcomes

• Change in Methacholine challenge dose per spirometry (Through study completion, up to 18 weeks)
• Changes in pre-bronchodilator FEV1 per spirometry (Through study completion, up to 18 weeks)

About This Study

The purpose of this study is to learn more about if taking a supplement called 5-hydroxytryptophan (5HTP) can improve breathing and anxiety symptoms related to asthma. To help learn more subjects will either be assigned to a group that is taking the supplement (5HTP) or a group that is taking a placebo. This will be decided randomly. Later in the study subjects will crossover to the other group.There are 5 study visits over the course of about 12 weeks.

Design

Interventions / Regimen

• Drug: 5-Hydroxytryptophan — Double blinded placebo controlled. 28 day dosing period followed by 3 week washout period. Then crossover to other arm of study
• Drug: Placebo — Double blinded placebo controlled. 28 day dosing period followed by 3 week washout period. Then crossover to other arm of study

Primary Outcomes

• Pulmonary Function Testing will be performed to assess for a change in Forced Expiratory Volume at one second (FEV1) (77 days)