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

U

University of Granada (UGR)

Status

Unknown

Conditions

Diabetes
Obesity

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT01634464
P06-CTS-02341
334602 Preobe Follow Up (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Enrollment

300 estimated patients

Sex

Female

Ages

18 to 42 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

300 participants in 4 patient groups

Control group
Description:
women with 18.5 \> BMI \< 25
Pregnant women with overweight
Description:
BMI≥25 before the pregnancy
Pregnant women with obesity
Description:
BMI≥30 before the pregnancy
Pregnant women with gestational diabetes
Description:
Gestational diabetes

Trial contacts and locations

1

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Central trial contact

Cristina Campoy, Professor, MD

Data sourced from clinicaltrials.gov

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