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Incidence of gestational diabetes mellitus (GDM) and the Mediterranean diet

Incidence of gestational diabetes mellitus (GDM) with different components of the Mediterranean diet

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16896947
Enrollment
500
Registered
2016-06-21
Start date
2016-09-01
Completion date
Unknown
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes Mellitus Nutritional, Metabolic, Endocrine

Interventions

Women will be assigned to the "olive oil" group with recommendations of consuming at least 1/2l of olive oil weekly or the "nuts" group where 75 g of nuts will be provided weekly. All women will be ad

Sponsors

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)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Incidence of gestational DM in each group diagnosed with a 75 g oral glucose load by IADPSG criteria at 24-28 gestational weeks.

Secondary

MeasureTime frame
1. Incidence of pre-eclampsia during pregnancy, as assessed using a blood pressure measurement 2. Number of instrumental delivery and caesarean sections at birth, as assessed using obstetric medical records 3. Number of small for gestational age new-borns, macrosomic new-borns, assessed using birth weight 4. Number of admissions to the paediatric intensive care unit at birth Added 29/07/2016: 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

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026