PRegnancy Outcomes and Maternal Insulin Sensitivity

Recruiting

Conditions: 10010273
10024450
Gestational diabetes mellitus
pregnancy diabetes
10018424

Registration Number: NL-OMON48381

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 130

Inclusion Criteria

- Healthy singleton pregnant women (10-12 weeks of gestation)
- BMI *25 kg/m2
- Fasting Blood Glucose (FBG *7.0 mmol/l)
- Dutch or English speaking
- Written informed consent

Exclusion Criteria

- Serious health complications (Hypertension, Hyperlipidemia, Asthma, Haemochromatosis) or medication use that influence the glucose metabolism or fetal growth (e.g. corticosteroids).
- Multiple pregnancy
- pre-existing Diabetes type 1 and 2 defined as FBG *7.0 mmol/l or use of diabetes medication
- Participation in any other studies involving the investigation of medication or nutritional products or antibiotic use in the two weeks prior to entry into the study
- HIV/Hepatitis
- Expectation of non-compliance to the study protocol, among others, a fear of needles
- Known allergies or intolerances for nutritional ingredients in the MTT
- Psychological dysfunctions

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>-Fasting levels of: glucose and insulin<br /><br>-PP responses of: glucose and insulin collected at t=0,10, 20,30,45,60,90 and<br /><br>120 min after the MTT or OGTT. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters:<br /><br>- fasting levels of total cholesterol, high density lipoprotein (HDL),<br /><br>triglycerides, free fatty acids, HbA1c, human placental lactogen, leptin, and<br /><br>cortisol.<br /><br>- Maternal anthropometrics and adiposity measures<br /><br>- Fetal growth and adiposity sonography measures<br /><br>- Neonatal growth and adiposity measures<br /><br>- Maternal, fetal and neonatal complications<br /><br><br /><br>Exploratory sudy parameters:<br /><br>- fasting and postprandial levels of stable glucose isotopes<br /><br>- neonatal eating behaviour<br /><br>- Lifestyle questionnaires </p><br>