Gestational diabetes mellitus pregnancy diabetes
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Healthy singleton pregnant women (10-12 weeks of gestation) - BMI >=25 kg/m2 - Fasting Blood Glucose (FBG
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Fasting levels of: glucose and insulin -PP responses of: glucose and insulin collected at t=0,10, 20,30,45,60,90 and 120 min after the MTT or OGTT. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters: - fasting levels of total cholesterol, high density lipoprotein (HDL), triglycerides, free fatty acids, HbA1c, human placental lactogen, leptin, and cortisol. - Maternal anthropometrics and adiposity measures - Fetal growth and adiposity sonography measures - Neonatal growth and adiposity measures - Maternal, fetal and neonatal complications Exploratory sudy parameters: - fasting and postprandial levels of stable glucose isotopes - neonatal eating behaviour - Lifestyle questionnaires | — |
Countries
Netherlands