RecruitingNot ApplicableNCT06152588

Restricted Eating Time in the Treatment of Type 2 Diabetes

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

Sponsor

Steno Diabetes Center Copenhagen

Enrollment

160 participants

Start Date

Mar 21, 2024

Study Type

INTERVENTIONAL

Conditions

Type 2 Diabetes

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether time-restricted eating (TRE) — limiting food intake to a shorter window during the day, typically 8–10 hours — can help manage blood sugar levels and other health outcomes in people with type 2 diabetes who are overweight or obese. Participants will wear a continuous glucose monitor (CGM) to track their blood sugar in real time. **You may be eligible if...** - You are 18 years or older - You have type 2 diabetes with an HbA1c above 53 mmol/mol (roughly 7%) - You are overweight or obese (BMI ≥ 25) - Your typical eating window is 12 hours or more per day **You may NOT be eligible if...** - You have had or are planning bariatric (weight loss) surgery - You use fast-acting insulin or combination insulin products - You already use a continuous glucose monitor regularly - You plan to follow Ramadan fasting during the study - You are pregnant, planning to become pregnant, or breastfeeding - You have severe hypoglycemia (dangerously low blood sugar requiring someone else's help) in the past year - You have serious heart, lung, kidney, or psychiatric conditions 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

OTHERTime 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.