RecruitingNot ApplicableNCT05365529

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

Feasibility and Efficacy of Time-Restricted Eating in Diabetes Management


Sponsor

University of California, San Diego

Enrollment

60 participants

Start Date

May 16, 2022

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether limiting the hours you eat each day (called time-restricted eating) can help control blood sugar in people with type 2 diabetes. Researchers want to see if eating within a shorter window of time improves blood sugar levels without changing medications. **You may be eligible if...** - You are 18–75 years old - You have type 2 diabetes with an HbA1c (blood sugar average) between 6.5% and 9% - You are on stable diabetes medications (not insulin) - You own a smartphone (iPhone or Android) - You currently eat over a 12-hour window each day **You may NOT be eligible if...** - You have type 1 diabetes or take insulin or sulfonylureas - Your HbA1c is above 9% - Your BMI is above 50 - Your blood pressure is very high (above 160/110 mmHg) - You are pregnant, breastfeeding, or planning to become pregnant - You have a history of eating disorders or had weight-loss surgery - You have severe kidney disease (eGFR below 30) - You have had a major heart event (heart attack, stroke) in the past year - You work night shifts or rotating schedules Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Altman Clinical and Translational Research Institute

La Jolla, California, United States

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NCT05365529


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