We hypothesize that TRE improves insulin sensitivity, glucose values, and consequently neonatal and maternal outcomes in GDM, via strengthening of clock gene expression rhythms.
ID
Bron
Verkorte titel
Aandoening
Gestational diabetes mellitus
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
• average 2-hour postprandial glucose levels
• average fasting glucose levels
Achtergrond van het onderzoek
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.
Doel van het onderzoek
We hypothesize that TRE improves insulin sensitivity, glucose values, and consequently neonatal and maternal outcomes in GDM, via strengthening of clock gene expression rhythms.
Onderzoeksopzet
Admission, 4 weeks after admission and the last visit before expected delivery date
Onderzoeksproduct en/of interventie
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.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL9393 |
Ander register | METC AMC : METC 2019_259 |