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

Inclusion Criteria4

Age: ≥18 years
Overweight or obesity (BMI ≥25 kg/m2)
T2D with HbA1c\>53 mmol/mol
Habitual eating window ≥12 h/day (incl. foods/snacks and energy-containing beverages)

Exclusion Criteria13

Bariatric surgery or planned bariatric surgery within study duration
Use of fast acting insulin and combination insulin products
Habitual CGM use
A wish to adhere to Ramadan
For women: current/planned pregnancy or lactation
Alcohol or drug abuse (judged by investigator) or treatment with disulfiram
Severe hypoglycaemia within last year (Severe hypoglycaemia, as defined by the American Diabetes Association (ADA), denotes severe cognitive impairment requiring external assistance for recovery)
Inability to understand written and oral information in Danish
Unable or unwilling to adhere to TRE; for instance, due to competing medical conditions.
Medical condition which, based on investigators assessment, challenges participation including but not limited to severe heart, vascular or lung disease, cancer, chemotherapy, psychiatric, gastrointestinal, rheumatic, or endocrine diseases etc.
Concomitant participation in other intervention study
Inability to perform neuropsychological tests (e.g., severe vision and hearing impairment that can-not be improved with aids such as glasses and hearing aids, or language barrier.)
Participants who do not wish to be informed about accidental findings by MR.

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.