Feasibility and Efficacy of Time-Restricted Eating in Diabetes Management
University of California, San Diego
Summary
This is a randomized clinical trial to assess the feasibility and efficacy of time-restricted eating (TRE) to improve glucose regulation and cardiovascular health of participants with type 2 diabetes mellitus (T2DM). Participants will be randomized into 2 groups: 1) standard of care (SOC), in which they will continue to follow their physician's treatment plan, or 2) SOC and TRE (8-10 hours eating window).
Description
The intervention will last for 12 weeks with a follow-up assessment at 6 months. This study will deliver the intervention, monitor participant health for safety, and promote compliance through clinic visits, virtual consultations, and an innovative combination of sensors, including continuous glucose monitors, actiwatches (to assess activity and sleep patterns), and the myCircadianClock smartphone app (to capture food, beverage, and medicine intake in real time). In-depth clinical and analytical measurements will be conducted at baseline and at the end of the intervention. We hypothesize that…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria 1. Age: 18-75 years old 2. Patients with T2DM with A1c between 6.5 and 9.0 % and on stable doses of medications who are weight-bearing and self-ambulatory. 3. Own a smartphone (Apple iOS or Android OS) 4. Baseline eating period ≥12 hours/day and sufficient logging on the mCC app. 5. Women of childbearing age will be given a pregnancy test on study enrollment and asked to use contraception throughout the study. 6. Post-menopausal and women on hormone replacement therapy will be included. 7. Estimated Glomerular Filtration Rate (EGFR) \> 30mL/min/1.73m2 8. If participants are…
Interventions
- BehavioralTime-Restricted Eating
Participants in the TRE group with continue to follow their physicians treatment plan for type II diabetes mellitus and consume all of their food within an 8-10 hour eating window.
- BehavioralStandard of Care
Participants in the Standard of Care group will continue to follow their physician's treatment plan for type II diabetes mellitus.
Location
- Altman Clinical and Translational Research InstituteLa Jolla, California