Effects of Exercise Timing and Diet on Type 2 Diabetes Management
Exercise Time of Day for Cardiometabolic Health in Type 2 Diabetes
This study is testing whether exercising at different times of the day, along with diet tips from a mobile app, can help adults with type 2 diabetes manage their weight and health better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 30 Years to 70 Years |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Locations | 3 sites (New Brunswick, New Jersey and 2 other locations) |
| Trial ID | NCT05108987 on ClinicalTrials.gov |
What this trial studies
This study investigates how the timing of exercise, either in the morning or afternoon, combined with dietary advice from the Noom mobile application, affects adults with type 2 diabetes. The researchers aim to determine if this combined approach leads to better adherence to dietary recommendations and improved weight loss, as well as enhanced metabolic and vascular health. By focusing on the optimal time of day for exercise, the study seeks to address common challenges in managing diabetes, such as insulin resistance and cardiovascular health. Participants will engage in an exercise program while receiving dietary guidance to assess the overall impact on their health outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 30 to 70 with a body mass index between 28 and 45 who have been diagnosed with type 2 diabetes.
Not a fit: Patients who are morbidly obese, have type 1 diabetes, or are on insulin therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for type 2 diabetes, enhancing weight loss and cardiovascular health for patients.
How similar studies have performed: While some studies have explored exercise timing and dietary adherence, this specific combination of interventions is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female \>30 and \<70 years old. * Has a body mass index \>28 and \<45 kg/m2. * Previously diagnosed with T2DM. * Subjects currently taking medications that affect heart rate and rhythm (i.e. Ca++ channel blockers, nitrates, alpha- or beta-blockers). Exclusion Criteria: * Morbidly obese patients (BMI \>46 kg/m2) and overweight/lean patients (BMI \<27 kg/m2) * Evidence of type 1 diabetes and diabetics requiring insulin therapy * Subjects who have not been weight stable (\>2 kg weight change in past 3 months) * Subjects who have been recently active (\>30 min of moderate/high intensity exercise, 2 times/week). * Subjects who are smokers or who have quit smoking \<1 years ago * Subjects with abnormal estimated glomerular filtration rate (eGFR). * Hypertriglyceridemic (\>400 mg/dl) and hypercholesterolemic (\>260 mg/dl) subjects * Hypertensive (\>160/100 mmHg) * Subjects with a history of significant metabolic, cardiac, congestive heart failure, cerebrovascular, hematological, pulmonary, gastrointestinal, liver, renal, or endocrine disease or cancer that in the investigator's opinion would interfere with or alter the outcome measures or impact subject safety. * Pregnant (as evidenced by positive urine pregnancy test) or nursing women * Subjects with contraindications to participation in an exercise training program * Currently taking active weight suppression medication (e.g. phentermine,orlistat, lorcaserin, naltrexone-bupropion in combination, liraglutide, benzephetamine, diethylpropion, phendimetrazine) * Known hypersensitivity to perflutren (contained in Definity)
Where this trial is running
New Brunswick, New Jersey and 2 other locations
- New Jersey Institute for Food, Nutrition, and Health — New Brunswick, New Jersey, United States (Recruiting)
- Robert Wood Johnson University Hospital Clinical Research Center — New Brunswick, New Jersey, United States (Recruiting)
- Rutgers University Loree Gymnasium — New Brunswick, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Steven K Malin, PhD — Rutgers University - New Brunswick
- Study coordinator: Steven K Malin
- Email: steven.malin@rutgers.edu
- Phone: 848-932-7054
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.