NCT05365529

Time-Restricted Eating for Type II Diabetes: TRE-T2D

Feasibility and Efficacy of Time-Restricted Eating in Diabetes Management

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 2
• Time Restricted Feeding
• Diabetes Type2

Interventions

Type	Name	Description
BEHAVIORAL	Time-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.
BEHAVIORAL	Standard of Care	Participants in the Standard of Care group will continue to follow their physician's treatment plan for type II diabetes mellitus.

Timeline

• Start date: 2022-05-16
• Primary completion: 2025-12-01
• Completion: 2026-03-01
• First posted: 2022-05-09
• Last updated: 2024-10-08

Locations

1 site across 1 country: United States