Restricted Eating Time in the Treatment of Type 2 Diabetes
Recruiting · NCT06152588 · Interventional (participants receive a specific treatment) · Lead sponsor: Steno Diabetes Center Copenhagen
View the official record on ClinicalTrials.gov →Interventions studied
Time restricted eating
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
2 locations listed.
- Steno Diabetes Center Copenhagen - Herlev, Denmark, Denmark
- Steno Diabetes Center Copenhagen - Herlev, Denmark, Denmark