Feasibility and Efficacy of Time-Restricted Eating in Diabetes Management
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- University of California, San Diego
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Glycemic regulation assessed by HbA1c
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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).
Detailed 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 TRE will result in improved glucose levels (assessed via Hemoglobin A1c, the gold standard in clinical trials of T2D) and improved cardiovascular health (assessed via LDL or "bad" Cholesterol and Triglycerides). We will also be examining long-term adherence to TRE and improvements in quality of life. The proposed study will be the first adequately powered, randomized trial of TRE in patients with T2DM on background medical therapy. It is founded on a strong scientific premise and utilizes rigorous study design, state-of-the-art methods for analyzing outcomes, and an innovative approach for engaging and sustaining participation. Successful completion of this clinical trial will lay the scientific foundation and establish safety parameters for widespread implementation of TRE in patients with T2DM.
Investigators
Pam Taub, MD
Professor of Medicine
University of California, San Diego
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Glycemic regulation assessed by HbA1c
Time Frame: Baseline and 3 months
Change in blood glucose assessed via hemoglobin A1c.
Secondary Outcomes
- Fasting plasma glucose (mg/dL)(Baseline and 3 months)
- LDL Particle Number (nmol/L)(Baseline and 3 months)
- Apolipoprotein B (ApoB)(Baseline and 3 months)
- Fasting plasma insulin (mIU/L)(Baseline and 3 months)
- HOMA-IR(Baseline and 3 months)
- Triglycerides (mg/dL)(Baseline and 3 months)
- Glycemic regulation assessed by Continuous Glucose Monitor (CGM)(Baseline and 3 months)
- Non-HDL Cholesterol (mg/dL)(Baseline and 3 months)
- Quality of life Assessment via Short Form-36 Questionnaire (SF-36)(Baseline and 3 months)