Status:
RECRUITING
Restricted Eating Time in the Treatment of Type 2 Diabetes
Lead Sponsor:
Steno Diabetes Center Copenhagen
Collaborating Sponsors:
University of Leeds
Salk Institute for Biological Studies
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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, car...
Detailed Description
In people with type 2 diabetes (T2D), weight loss is associated with improved glycaemic control and markers of cardiometabolic function as well as reduced use of antidiabetic medicine. Beyond pharmaco...
Eligibility Criteria
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
- 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.)
- Exclusion criteria for the sub-study:
- 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.
Key Trial Info
Start Date :
March 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06152588
Start Date
March 21 2024
End Date
May 1 2026
Last Update
May 16 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Steno Diabetes Center Copenhagen
Herlev, Denmark, Denmark, 2730