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

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus, Type 2; Time Restricted Feeding; Diabetes Type2
• Interventions: Behavioral: Standard of Care; Behavioral: Time-Restricted Eating

• Registration Number: NCT05365529
• Lead Sponsor: University of California, San Diego

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.

Study Timeline

• Study First Submitted: 2022-03-10
• Study First Submitted QC: 2022-05-03
• Study First Posted: 2022-05-09
• Study Start: 2022-05-16
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-08
• Primary Completion: 2025-12
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of Care	The participants in this arm will receive the standard health and nutritional wellness guidelines and will be required to log food entries through the use of a smartphone app.
Time-Restricted Eating	Time-Restricted Eating	The participants in this arm will limit the number of hours they eat in day to a 8-10-hour window and will also receive the standard health and nutritional wellness guidelines. They will also be required to log food entries through the use of a smartphone app.

Primary Outcome Measures

Name	Time	Method
Glycemic regulation assessed by HbA1c	Baseline and 3 months	Change in blood glucose assessed via hemoglobin A1c.

Secondary Outcome Measures

Name	Time	Method
Fasting plasma insulin (mIU/L)	Baseline and 3 months	Change in glycemic regulation as assessed changes in fasting plasma insulin (mIU/L).
HOMA-IR	Baseline and 3 months	Change in glycemic regulation as assessed by HOMA-IR.
Fasting plasma glucose (mg/dL)	Baseline and 3 months	Change in glycemic regulation as assessed fasting plasma glucose (mg/dL).
LDL Particle Number (nmol/L)	Baseline and 3 months	Changes in atherogenic lipids assessed via LDL Particle Number (nmol/L) via NMR Lipoproteinprofile.
Apolipoprotein B (ApoB)	Baseline and 3 months	Changes in atherogenic lipids assessed via ApoB (mg/dL).
Triglycerides (mg/dL)	Baseline and 3 months	Changes in atherogenic lipids assessed via Triglycerides (mg/dL).
Glycemic regulation assessed by Continuous Glucose Monitor (CGM)	Baseline and 3 months	Change in glycemic regulation as assessed by CGM from interstitial glucose with outcomes including time in range, glycemic variability, and mean glucose.
Non-HDL Cholesterol (mg/dL)	Baseline and 3 months	Changes in atherogenic lipids assessed via Non-HDL Cholesterol (mg/dL).
Quality of life Assessment via Short Form-36 Questionnaire (SF-36)	Baseline and 3 months	Changes in quality of life as assessed by the SF-36 questionnaire.

Trial Locations

Locations (1)

Altman Clinical and Translational Research Institute; 🇺🇸 La Jolla, California, United States