Time restricted eating to treat gestational diabetes mellitus
- Conditions
- Gestational diabetes mellitus
- Registration Number
- NL-OMON23529
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 38
Inclusion Criteria
singleton pregnancy
- diagnosis of GDM (fasting plasma glucose >6.1 mmol/l or 2 hr 75g OGTT value >7.8 mmol/l)
- adequate control of Dutch or English language
- eating during a period of >11 hours during a typical weekday.
- amenorrhea duration at time of inclusion =34 weeks
Exclusion Criteria
- pre-existing diabetes mellitus
- glucocorticoid induced diabetes mellitus
- non-singleton pregnancy
- circadian rhythm sleep disorders as defined in the DSM-5
- shift work during pregnancy
- repeatedly crossing >2 time zones during pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method • average 2-hour postprandial glucose levels<br>• average fasting glucose levels
- Secondary Outcome Measures
Name Time Method • blood glucose time in range<br>• average blood glucose<br>• need for glucose lowering drugs <br>• neonatal birth weight <br>• fasting glucose 6 weeks post-partum <br>• maternal bodyweight gain <br>• maternal sleep quality <br>• pregnancy complications <br>• neonatal complications <br>• participant satisfaction with the diet<br>