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

Obesity Clinical Trial

— PREOBE  

Official title:

The Role of Nutrition and Maternal Genetics on the Programming of Development of Fetal Adipose Tissue. Search for Markers of the Obesity Risk in Early Stages of Life

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01634464
• Other study ID #: P06-CTS-02341
• Secondary ID: 334602 Preobe Fo
• Status: Recruiting
• Phase: N/A
• First received: March 19, 2012
• Last updated: July 5, 2012
• Start date: March 2007
• Est. completion date: June 2013

Study information

• Verified date: July 2012
• Source: Universidad de Granada
• Contact: Cristina Campoy, Professor, MD
• Phone: 0034 629308695
• Email: ccampoy[@]ugr.es
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2013
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes
• Obesity

Locations

Country	Name	City	State
Spain	Department of Pediatrics, School of Medicine, University of Granada	Granada

Sponsors (10)

Lead Sponsor	Collaborator
Universidad de Granada	Abbott, Agencia Andaluza del Conocimiento, ICTAN-CSIC - Madrid - Spain, Ludwig-Maximilians - University of Munich, Scottish Government NuGO EU Project, Spanish-Andalusian Ministry of Economy, Innovation and Science, University of Aberdeen, University of Barcelona, University of Nottingham

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Campoy C, Martín-Bautista E, García-Valdés L, Florido J, Agil A, Lorente JA, Marcos A, López-Sabater MC, Miranda-León T, Sanz Y, Molina-Font JA; grupo PREOBE. [Study of maternal nutrition and genetic on the foetal adiposity programming (The PREOBE study)] — View Citation

Santacruz A, Collado MC, García-Valdés L, Segura MT, Martín-Lagos JA, Anjos T, Martí-Romero M, Lopez RM, Florido J, Campoy C, Sanz Y. Gut microbiota composition is associated with body weight, weight gain and biochemical parameters in pregnant women. Br J — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No

External Links

•   Official website for the PREOBE Project