Gestational Diabetes Mellitus Nutritional, Metabolic, Endocrine Diabetes mellitus arising in pregnancy
Conditions
Interventions
Eligible women will be randomly assigned to one of two groups:
1. Control group: Women are assigned to standard treatment with recommendations to reduce all types of fat from both anim
Sponsors
The Health Research Institute at the Hospital Clinico San Carlos (Spain)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women aged over 18 2. With normal fasting glucose values (< 92 mg/dl) in the 1st gestational assessment (8-12 GWs) 3. Who sign the informed consent Added 30/08/2017: 4. Having attended GDM screening at 24-28 gestational weeks Added 26/01/2018: 5. Who did not develop GDM
Exclusion criteria
Exclusion criteria: 1. Women with fasting glucose levels >92 mg/dl in the 1st gestational assessment (8-12 GWs) 2. Multiple pregnancy 3. Nut allergy or any other medical condition 4. Ongoing medication 5. Significant disability that would prevent the participant from complying with trial consent, treatment and follow-up procedures or potentially jeopardize her medical care Added 26/01/2018: 6. GDM diagnosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To define the prevention of GDM (evaluated at 24-28 GWs with HAPO criteria) after the lifestyle intervention based on MedDiet and physical activity/exercise, as compared to standard treatment, in women with normal FPG at the 1st gestational visit (8-12 GWs). Added 26/01/2018: The primary outcome will be to compare the incidence of composite maternofoetal outcomes in normoglycemic women who followed two different nutritional recommendations ? guidelines based on a MedDiet with an enhanced consumption of extra virgin olive oil and nuts versus guidelines provided in regular clinical practice that limit fat consumption. Composite maternofoetal outcomes assessed were emergency c-section, perineal trauma, pregnancy induced hypertension, preeclampsia, prematurity, large-for-gestational-age, and small-for-gestational-age. Added 30/08/2017: Follow up study: To evaluate normoglycemia (HbA1c and glycemia levels) and gestational weight gain in both groups of women. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To define the parameters of gestation length, fetal development, delivery characteristics such as cesarean delivery and instrumental vaginal birth, placental weight, and newborn data such as newborn weight, Apgar test values, and cord blood pH. Timepoint: at delivery, Visit 4. 2. To define functional genetic risk of developing GDM focusing on obese and non-obese pregnant women. Method and timepoint: HumanOmniExpress Infinium Illumina Exome v1.0, which allows the genotyping of approximately 950,000 markers in total sample. Of these, 700,000 are included in the common variants HumanOmniExpress Infinium (MAF> 5%) and 250,000 variants are included in the Human Exon Exome BeadChip. Eight samples can be hybridized per chip. Measured at Visit 0. 3. To investigate the effects of MedDiet and scheduled physical exercise/activity on inflammatory biomarkers in pregnant women. Method and timepoint: adiponectin, leptin, insulin and proinsulin will be determined by radioimmunoassay (Linco SA). hsCRP, sCD40L and Lp-PLA2 will be determined by specific ELISA kits. Visit 0-6. 4. To investigate the effects of MedDiet and scheduled physical exercise/activity on epigenetic mechanisms (DNA methylation and miRNA expression) in pregnant women and their offspring. If confirmed, it would represent a novel epigenetic mechanism for regulation of gene expression in the offspring (method and timepoint: we will perform a genome-wide DNA methylation analysis with the Illumina HumanMethylation450 BeadChip, following the Illumina Infinium HD Methylation protocol, using DNA obtained from whole blood. Quantitative methylation-specific PCR assay [qMSP]: validation of the most significant loci. Quantitative MSP will be performed with a 7500 Real-Time PCR System (Applied Biosystems). The primers will be designed using the MethPrimer website. Visit 0-2-4-6. 5. To investigate whether the MedDiet and scheduled physical exercise/activity alter | — |
Countries
Spain
Outcome results
None listed