Role of Nutrition and Maternal Genetics on the Programming of Development of Fetal Adipose Tissue

• Conditions: Obesity; Diabetes

• Registration Number: NCT01634464
• Lead Sponsor: Universidad de Granada

Brief Summary

In the PREOBE projects it is aimed to obtain genetic and biochemical biomarkers for the programming of obesity in early stages of life. This can be achieved by studying pregnant women with normal weight, overweight, obesity and gestational diabetes, and by analyzing how these conditions could impact on fetal growth and development; the risk of obesity in the offspring during the first 3 years of life will be also assessed (genetic polymorphisms of the most recognized genes related to obesity; gene expression of placental biomarkers indicators of early programming, polyunsaturated fatty acids, immunological and pro-inflammatory markers, analysis of endogenous and exogenous lipid peroxidation, allergies \& neurodevelopmental assessment...). Moreover, the interaction of pathological maternal conditions with confounder factors that could have a role in the proposed outcomes will be also studied (maternal and child dietary intake, medical history and socioeconomic \& environmental factors).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2010-10
• Study First Submitted: 2012-03-19
• Status Verified: 2012-07
• Study First Submitted QC: 2012-07-02
• Last Update Submitted: 2012-07-05
• Study First Posted: 2012-07-06
• Last Update Posted: 2012-07-09
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• healthy pregnant women aged between 18 and 42
• singleton pregnancies
• pregnancy stage at recruitment: 12 weeks of pregnancy

Exclusion Criteria

• Women who wish to participate in the study should not simultaneously participate in other research studies.
• Must be completely enclosed in one of the study of the groups without any possibility to be simultaneously incorporated on more groups of the study
• Mothers which are receiving any drug treatment, folate more than the 3rd first months, or DHA +/- vitamin supplements during pregnancy.
• Mothers affected by any disease other than those referred to the inclusion criteria, such hypertension or pre-eclampsia, foetal IUGR, mother infection during pregnancy, hypothyroidism / hyperthyroidism, hepatic diseases, renal disease,...
• Mothers following an extravagant diet or vegan diet.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Long-term evidence of early human programming of obesity measured by nutritional biomarkers, and the offspring growth and development.	Participants will be followed for the duration of the study, an expected average of 6 years
Long-term evidence of early human programming of obesity measured by genetic biomarkers, and the offspring growth and development.	Participants will be followed for the duration of the study, an expected average of 6 years
Long-term evidence of early human programming of obesity measured biochemical perinatal biomarkers, and the offspring growth and development.	Participants will be followed for the duration of the study, an expected average of 6 years

Trial Locations

Locations (1)

Department of Pediatrics, School of Medicine, University of Granada; 🇪🇸 Granada, Spain