Time restricted eating to treat gestational diabetes mellitus

Recruiting

Conditions: gestational diabetes mellitus
10018424
10010273

Registration Number: NL-OMON55092

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

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. (Preliminary
data from an ongoing questionnaire study at our centre suggests an estimated
29% of OGTT positive patients already practice TRE by eating <=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
<p>Will be assessed at the week following; the start of study, week 4,8 and 12.<br /><br>• average 2-hour postprandial glucose levels<br /><br>• average fasting glucose levels</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• feasibility of study (compliance)<br /><br>• blood glucose time in range<br /><br>• average blood glucose values<br /><br>• Hepatic steatosis and fibrosis<br /><br>• need for glucose lowering drugs<br /><br>• neonatal birth weight<br /><br>• fasting glucose 6 weeks post-partum<br /><br>• maternal bodyweight gain<br /><br>• maternal sleep quality<br /><br>• pregnancy complications<br /><br>• neonatal complications<br /><br>• participant satisfaction with the diet </p><br>