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Time restricted eating to treat gestational diabetes mellitus

Time restricted eating to treat gestational diabetes mellitus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23529
Enrollment
38
Registered
2021-03-31
Start date
2021-04-12
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational diabetes mellitus

Interventions

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

Sponsors

Amsterdam UMC
Lead Sponsor

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. - amenorrhea duration at time of inclusion =34 weeks

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

MeasureTime frame
• average 2-hour postprandial glucose levels • average fasting glucose levels

Secondary

MeasureTime frame
• 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

Contacts

Public ContactDion Muller

Amsterdam UMC, location AMC

d.r.muller@amsterdamumc.nl0617381736

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)