Status:
COMPLETED
Feasibility of Time-Restricted Eating in the Treatment of Type 2 Diabetes
Lead Sponsor:
Kristine Færch
Collaborating Sponsors:
Hvidovre University Hospital
University of Leeds
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The overall aim of this pilot study is to examine feasibility of a 12-week 10-hour time-restricted eating intervention in individuals with overweight or obesity and type 2 diabetes. The results of the...
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)
- Associated with the T2D clinic at Steno Diabetes Center Copenhagen (SDCC) or Hvidovre Hospital
Exclusion
- Weight loss \>5kg last 3 months
- Bariatric surgery or planned bariatric surgery within study duration
- Use of fast acting insulin and combination insulin products
- Unable or unwilling to adhere to time-restricted eating; for instance, due to competing medical conditions.
- 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, denotes severe cognitive impairment requiring external assistance for recovery)
- Inability to understand written and oral information in Danish.
- Diagnosed with an eating disorder in the past 3 years
- 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
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05375695
Start Date
April 1 2022
End Date
November 15 2022
Last Update
November 17 2022
Active Locations (1)
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1
Steno Diabetes Center Copenhagen
Herlev, Denmark, 2730