NCT06152588Recruiting
Restricted Eating Time in the Treatment of Type 2 Diabetes
Restricted Eating Time in the Treatment of Type 2 Diabetes - the RESET2 Trial.
Source: ClinicalTrials.gov · Last updated 16 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 27 Oct 2023
- Start date
- 21 Mar 2024
- Primary completion date
- 1 May 2026
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT06152588
What you commit to
- Study type: Interventional
- Planned participants: 160
- From 21 Mar 2024 to the primary completion date, 1 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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.)
Other
- 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.
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Steno Diabetes Center Copenhagen Coordinator of this site? Confirm its status | Herlev | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.