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ID
Source
Brief title
Health condition
Gestational diabetes mellitus
Sponsors and support
Intervention
Outcome measures
Primary outcome
• average 2-hour postprandial glucose levels
• average fasting glucose levels
Secondary outcome
• blood glucose time in range
• average blood glucose
• need for glucose lowering drugs
• neonatal birth weight
• fasting glucose 6 weeks post-partum
• maternal bodyweight gain
• maternal sleep quality
• pregnancy complications
• neonatal complications
• participant satisfaction with the diet
Background summary
Gestational diabetes mellitus (GDM) poses major health risks to a pregnant woman and the fetus. It has been proven that the reduction of glucose levels in GDM reduces pregnancy complication risks. Dietary advice is the first step in the treatment of gestational diabetes mellitus, but there is little knowledge about the optimal dietary treatment. Time restricted eating (TRE) is the reduction of the eating period to a consistent daily 4-12 hr period. The rationale is that with appropriately timed TRE, the periods of food intake and fasting are synchronized with the rhythm of the circadian timing system, and thereby the functioning of the circadian tissue clocks is improved. Several studies indicate that TRE is a promising new approach in the prevention and treatment of diabetes mellitus. To date however TRE has not been investigated in pregnant women.
Study objective
We hypothesize that TRE improves insulin sensitivity, glucose values, and consequently neonatal and maternal outcomes in GDM, via strengthening of clock gene expression rhythms.
Study design
Admission, 4 weeks after admission and the last visit before expected delivery date
Intervention
All participants will receive standard care according to the current guidelines. The women in the TRE group will get the additional advice to restrict the daily period of food intake to a self-chosen 11- hr period. After 2 weeks they will further restrict food intake to a self-chosen 10-hr period.
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL9393 |
| Other | METC AMC : METC 2019_259 |