Primary Objective: 1. What is the difference in effectiveness of Early Time-restricted Eating (eTRE) in glycaemic regulation when compared to isocaloric continues caloric restriction (CCR) after one year in overweight adults with type 2 diabetes?…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Health condition
Type 2 Diabetes
Research involving
Sponsors and support
Intervention
- Food (substances)
Outcome measures
Primary outcome
Between-group difference in HbA1c (mmol/mol) from baseline to one year. HbA1c will be measured with routine clinical lab procedures
Secondary outcome
• Body composition • Cardiovascular risk factors • Resting Energy Expenditure • Quality of life • Demographic variables, drug use, smoking and drinking habits, exercise and (diabetes) medication use • Food intake, adherence to the diet interventions and compliance to the time restriction • Patient satisfaction • Chronotype score • Sleep quality • Chrononutrition score • Attrition • Satisfaction and feedback of provided lifestyle book • Process evaluation
Background summary
Type 2 diabetes prevalence is steadily increasing . Risks are increased in those with overweight or obesity. Weight loss reduces cardiovascular risk and may even lead to remission of diabetes. There is no consensus yet on the most effective weight loss strategy for T2D. Early time restricted eating (eTRE), a form of intermittent fasting, has shown great potential in improving glycaemic regulation in patients with prediabetes. However, eTRE has not been studied in people with T2D and obesity.
Study objective
Primary Objective: 1. What is the difference in effectiveness of Early Time-restricted Eating (eTRE) in glycaemic regulation when compared to isocaloric continues caloric restriction (CCR) after one year in overweight adults with type 2 diabetes? Secondary Objective(s): 2. What is the difference in weight loss, body composition, cardiovascular risk factors and diabetic medication usage between a CCR and eTRE after one year in overweight adults with type 2 diabetes? 3. What is the difference in quality of life, treatment satisfaction, compliance, and adherence between the two diet interventions? 4. Is there an association between patient characteristics and the effectivity of the two diet interventions?
Study design
Baseline, 3 months, 6 months and 12 months
Intervention
Control group: group treatment with a carbohydrate restricted Mediterranean diet Intervention group: group treatment with a carbohydrate restricted Mediterranean diet and an eating window limited to 10 hours per day (eTRE)
Carmen Dietvorst
Dr. Molewaterplein 40
3015 GD
Rotterdam
Nederland
(010)7033055
c.dietvorst@erasmusmc.nl
Carmen Dietvorst
Dr. Molewaterplein 40
3015 GD
Rotterdam
Nederland
(010)7033055
c.dietvorst@erasmusmc.nl
Age
Inclusion criteria
• Diagnosed T2D
• BMI ≥ 27 kg/m2
• Aged 18 - 75 years
• Smartphone with android or IOS
Exclusion criteria
• Insufficient command of the Dutch language (spoken and written)
• Pregnancy or lactation during the trial
• Severe psychiatric disorders, use of antipsychotic drugs
• Serious heart conditions such as: significant heart arrhythmia, unstable angina pectoris, decompensated congestive heart failure
• Organ failure
• Untreated hypothyroidism
• End-stage renal failure
• Carcinomas
• Transplants, myocardial infarct, cerebrovascular accident, or any large-scale surgery within the last 3 months
• Corticosteroid induced diabetes (in patients still using corticosteroids)
• Start with GLP-1 agonists within the last 3 months
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9756 |
| CCMO | NL78344.078.21 |
| OMON | NL-OMON54132 |