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RECRUITING
NCT06152588
NA

Restricted Eating Time in the Treatment of Type 2 Diabetes

Sponsor: Steno Diabetes Center Copenhagen

View on ClinicalTrials.gov

Summary

The overall aim of the present study is to investigate the effectiveness of implementing a 1-year time-restricted eating (TRE)-based intervention on glycaemic control, body weight and composition, cardiometabolic risk factors, and behaviour in individuals with overweight/obesity and type 2 diabetes (T2D).

Official title: Restricted Eating Time in the Treatment of Type 2 Diabetes - the RESET2 Trial.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2024-03-21

Completion Date

2026-05-01

Last Updated

2025-05-16

Healthy Volunteers

No

Conditions

Interventions

OTHER

Time restricted eating

3 months (12 weeks) strict TRE intervention: Participants will be instructed to reduce their eating window by minimum 3 hours compared to habitual eating, with an eating window below 10 hours. The timing of the eating window is self-selected but should be placed between 6 am and 8 pm. Diet during the eating window is ad libitum with no further dietary restrictions. 9 months (40 weeks) individually adjusted TRE intervention: An individual plan will be made based on participants' experiences during the strict TRE. Different choices of individual adjustment and support will be provided, including 1) eating window adjustments and the possibility of 'days off', 2) provision of a list of allowed calorie and caffeine free beverages that can be consumed outside the window, 3) continued opportunity to participate in peer-support group meetings, 4) extra phone calls with a project worker to discuss challenges or strategies to continue with TRE etc., and 5) further involvement of relatives.

Locations (1)

Steno Diabetes Center Copenhagen

Herlev, Denmark, Denmark