Status:
COMPLETED
Effect of Time-restricted Eating on Behaviour and Metabolism in Overweight Individuals at High Risk of Type 2 Diabetes
Lead Sponsor:
Kristine Færch
Collaborating Sponsors:
University of Copenhagen
Aalborg University Hospital
Conditions:
Overweight and Obesity
PreDiabetes
Eligibility:
All Genders
30-70 years
Phase:
NA
Brief Summary
The aim of the present study is to investigate effects of 12 weeks time-restricted eating on behaviour and metabolism in individuals with overweight or obesity at high risk of type 2 diabetes.
Detailed Description
Overweight and obese individuals with pre-diabetes or with a family history of diabetes or cardiovascular disease (CVD) are at high risk for developing type 2 diabetes (T2D) and CVD. Current preventio...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- BMI ≥30 kg/m2 or BMI ≥25 kg/m2 in combination with pre-diabetes (HbA1c ≥39-\<48 mmol/mol)
- Habitual eating/drinking window ≥12 hours (including foods/snacks and energy containing beverages e.g. soft drinks (except of water)) and an eating/drinking window of ≥14 hours minimum one day per week
- Exclusion criteria
- Daily smoking
- For women: pregnancy, planned pregnancy (within the study period) or lactating
- Frequent travels over time zones (max one return trip/travel over times zones (˃one hour time difference) during the 13 weeks intervention).
- Shift work or partner engaged in shift work (if it affects the person's sleep and eating pattern)
- Unable to understand the informed consent and the study procedures
- Self-reported history of an eating disorder during the past three years
- Self-reported weight change (\>5 kg) within three months prior to inclusion
- Diabetes
- HbA1c ≥48 mmol/mol
- Uncontrolled medical issues including but not limited to cardiovascular pulmonary, rheumatologic, hematologic, oncologic, infectious, gastrointestinal or psychiatric disease; diabetes or other endocrine disease; immunosuppression
- Current treatment with medication or medical devices which significantly affect glucose metabolism, appetite, or energy balance
- Current treatment with antidepressants
- Bariatric surgery
- Implanted or portable electro-mechanical medical device such as a cardiac pacemaker, defibrillator or infusion pump
- Celiac disease, Crohn's disease, ulcerative colitis or proctitis
- Alcohol/drug abuse or in treatment with disulfiram at time of inclusion
- Concomitant participation in other intervention studies
- Not able to eat ≥85% of the test meal because of e.g. allergy
- Specific exclusion criteria for participants receiving SmartPillTM (n=60)
- Gastrointestinal symptoms or diseases such as regular (weekly) abdominal pain, dysphagia, gastric bezoars, strictures, fistulas, bowel obstructions or diverticulitis
- Current treatment with medication or medical devices which significantly affect gastrointestinal motility or transit time (prokinetics, antidiarrheals, laxatives, or opioids)
- Gastrointestinal surgery within 3 months before inclusion
Exclusion
Key Trial Info
Start Date :
February 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03854656
Start Date
February 25 2019
End Date
March 2 2022
Last Update
March 18 2022
Active Locations (1)
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1
Steno Diabetes Center Copenhagen
Gentofte Municipality, Denmark, DK-2810