Gestational diabetes Pregnancy and Childbirth Diabetes mellitus in pregnancy
Conditions
Interventions
Interventions section as of 09/06/2016:
The design is that of two trials with a factorial design:
Trial 1:
1. Physical activity (PA)
2. Diet
3. PA & diet
4. Control
Trial 2:
1. Vitamin D
2. PA & d
Sponsors
VU University Medical Center (Netherlands)
Eligibility
Sex/Gender
Female
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Pre-pregnancy body mass index (BMI) (self-reported weight, measured height) is >= 29 kg/m2) 2. Aged 18 years or more 3. Gestational age at recruitment < 12 weeks 4. Sufficiently fluent in major language of the country of recruitment 5. Being able to be moderately physically active 6. Giving written informed consent 7. Agree to give birth in one of the participating hospitals
Exclusion criteria
Exclusion criteria: 1. Pre-existing diabetes 2. Diagnosed with (gestational) diabetes mellitus before randomisation, defined as fasting glucose = 5.1 mmol/l and/or 1 hour glucose = 10 mmol/l and/or 2 hour glucose = 8.5 mmol/l at baseline 3. Not able to walk at least 100 meters safely 4. Requirement for complex diets 5. Advanced chronic conditions (eg valvular heart disease) 6. Sgnificant psychiatric disease 7. Unable to speak major language of the country of recruitment fluently 8. Known abnormal calcium metabolism (hypo/hyperparathyroidism, nephrolithiasis, hypercalciuria) or hypercalciuria detected at screening (0.6 mmol/mmol creatinine in spot morning urine) 9. Twin pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Weight gain during pregnancy: women will be weighed at all three measurements, with a calibrated scale (Seca) 2. Fasting plasma glucose: The fasting plasma glucose test is performed after a person has fasted for at least 8 hours. A sample of blood is taken from a vein (antecubital region) in the arm 3. Insulin sensitivity will be measured using Homeostatic Model Assessment (HOMA), Quantitative insulin sensitivity check index (QUICKIE) and oral glucose insulin sensitivity (OGIS). OGIS also enables evaluation of insulin secretion. First phase insulin response will be calculated from the fasting and 30 min samples | — |
Secondary
| Measure | Time frame |
|---|---|
| Maternal parameters: 1. HbA1c, fasting C peptide, leptin, triglycerides, free fatty acids, high density lipoprotein cholesterol (HDL-C) and low density lipoprotein cholesterol (LDL-C), adiponectin 2. 3 beta-hydroxy-butyrate will be used as measures of alternative fuel supply; the latter also potentially a measure of excess weight loss and for safety studies 3. Blood pressure 4. C-reactive protein (CRP) will be measured as an indication for maternal inflammation 5. Change in physical activity will be assessed with a validated physical activity questionnaire and by accelerometer 6. Change in dietary habits will be assessed with a short food frequency questionnaire 7. All costs related to pregnancy and delivery: direct health care and non-health care costs and indirect non-health care costs will be assessed prospectively by questionnaires Foetal parameters: 1. For the assessment of how GDM affects the foetus, antenatal growth protocols for the following measurements will be developed: neonatal growth, adiposity, adipo-insular axis, glucose-insulin axis, electrolyte concentrations, clinical outcomes and hypoxia exposure at birth. Clinical measurements will be performed in all trial centers, laboratory measurements in the central laboratory on the samples collected in all trial centers. This will include: 1.1. Prenatally standardised ultrasound assessment of classic foetal growth parameters [biparietal diameter (BPD), head circumference (HC), abdominal circumference (AC), femur length (FL)] and determinants of foetal body composition variables (lean body mass and fat body mass). 1.2. At birth the following parameters will be recorded: Placental weight, birth weight and length, head and abdominal circumference, skin fold thickness (subcutaneous adipose tissue). In addition cord blood (arterial and venous) will be collected by all centers and sent to the central laboratory to measure C-peptide, glucose, leptin, triglycerides, 3- beta-hydroxy-butyric acid, pH and erythr | — |
Countries
Austria, Belgium, Denmark, England, Ireland, Italy, Netherlands, Poland, Spain, United Kingdom
Outcome results
None listed