Incidence of gestational diabetes mellitus (GDM) and the Mediterranean diet
Not Applicable
- Conditions
- Gestational Diabetes MellitusNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN16896947
- Lead Sponsor
- Biomedical Research Institute (IdISSC) Foundation for Biomedical Research, Clinico San Carlos Hospital (Instituto de Investigación Biomédica (IdISSC) Fundación para la Investigación Biomédica, Hospital Clínico San Carlos)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped
- Sex
- Female
- Target Recruitment
- 500
Inclusion Criteria
1. Pregnant women at least 18 years old
2. Normal fasting blood glucose values in the first gestational assessment
Added 29/07/2016:
3. BMI >25 and <35
Exclusion Criteria
1. Women with fasting blood glucose >92 mg/dl in the first gestational assessment
2. Nuts or olive oil intolerance
3. Multiple pregnancy and any medical condition, treatment or diet intervention that the medical team consider to influence the effects of the study intervention.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of gestational DM in each group diagnosed with a 75 g oral glucose load by IADPSG criteria at 24-28 gestational weeks.
- Secondary Outcome Measures
Name Time Method <br> 1. Incidence of pre-eclampsia during pregnancy, as assessed using a blood pressure measurement<br> 2. Number of instrumental delivery and caesarean sections at birth, as assessed using obstetric medical records<br> 3. Number of small for gestational age new-borns, macrosomic new-borns, assessed using birth weight<br> 4. Number of admissions to the paediatric intensive care unit at birth<br><br> Added 29/07/2016:<br> 5. Weight gain is assessed by calculating BMI from height and weight at the 8-12 weeks gestational visit and the 38 gestational week visit<br>