Tests a time-limited eating schedule in adults with type 2 diabetes
Tests a daily eating window in adults with type 2 diabetes and excess weight.
Plain-language title generated from the registry record
Registry title: Restricted Eating Time in the Treatment of Type 2 Diabetes
Key facts
- Where
- Herlev, DenmarkSee the site
Where in Denmark
- Steno Diabetes Center CopenhagenHerlev, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Steno Diabetes Center Copenhagen
- Trial code
- NCT06152588
- Record updated
- 16 May 2025
- Original description
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).Read full original descriptionShow less
Restricted Eating Time in the Treatment of Type 2 Diabetes - the RESET2 Trial.
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).
Inclusion: 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: Bariatric surgery or planned bariatric surgery within study duration; Alcohol or drug abuse (judged by investigator) or treatment with disulfiram; Concomitant participation in other intervention study; Severe hypoglycaemia within last year (Severe hypoglycaemia, as defined by the American Diabetes Association (ADA), denotes severe cognitive impairment requiring external assistance for recovery); 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; 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.); 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; Inability to understand written and oral information in Danish; Magnetic resonance imaging (MRI) contraindications based on the MR department's exclusion criteria including pacemaker or other implanted electronic devices, implanted metal objects not compatible to MRI scanning and severe claustrophobia; Participants who do not wish to be informed about accidental findings by MR.