gestational diabetes mellitus
Conditions
Interventions
The intervention group will adhere to a TRE-regimen in addition to receiving
the standard care as is given according to protocol in gestational diabetes
mellitus. The control group will solely be gi
Sponsors
Academisch Medisch Centrum
Eligibility
Inclusion criteria
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. (Preliminary data from an ongoing questionnaire study at our centre suggests an estimated 29% of OGTT positive patients already practice TRE by eating
Exclusion criteria
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Will be assessed at the week following; the start of study, week 4,8 and 12. • average 2-hour postprandial glucose levels • average fasting glucose levels | — |
Secondary
| Measure | Time frame |
|---|---|
| • feasibility of study (compliance) • blood glucose time in range • average blood glucose values • Hepatic steatosis and fibrosis • 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 | — |
Countries
Netherlands
Outcome results
None listed