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

July 5, 2012 updated by: Cristina Campoy, Universidad de Granada

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

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).

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Granada, Spain, 18012
        • Recruiting
        • Department of Pediatrics, School of Medicine, University of Granada
        • Contact:
          • Cristina Campoy, Professor, MD
          • Phone Number: 0034 629308695
          • Email: ccampoy@ugr.es

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

A total of 350 pregnant women aged between 18 and 42, with singleton pregnancies, were recruited at 12 weeks of pregnancy at the Clinical University Hospital 'San Cecilio' and "Mother-Infant" Hospital in the city of Granada, Spain

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control group
women with 18.5 > BMI < 25
Pregnant women with overweight
BMI≥25 before the pregnancy
Pregnant women with obesity
BMI≥30 before the pregnancy
Pregnant women with gestational diabetes
Gestational diabetes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Long-term evidence of early human programming of obesity measured by nutritional biomarkers, and the offspring growth and development.
Time Frame: Participants will be followed for the duration of the study, an expected average of 6 years
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.
Time Frame: Participants will be followed for the duration of the study, an expected average of 6 years
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.
Time Frame: Participants will be followed for the duration of the study, an expected average of 6 years
Participants will be followed for the duration of the study, an expected average of 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Granada

Collaborators

University of Nottingham
Ludwig-Maximilians - University of Munich
Abbott
University of Aberdeen
Ministerio de Economía y Competitividad, Spain
University of Barcelona
Scottish Government NuGO EU Project
ICTAN-CSIC - Madrid - Spain
Andalusian Agency of Knowledge

Investigators

  • Study Director: Cristina Campoy, Professor, MD, Universidad de Granada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

October 1, 2010

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

March 19, 2012

First Submitted That Met QC Criteria

July 2, 2012

First Posted (Estimate)

July 6, 2012

Study Record Updates

Last Update Posted (Estimate)

July 9, 2012

Last Update Submitted That Met QC Criteria

July 5, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P06-CTS-02341
  • 334602 Preobe Follow Up (Other Grant/Funding Number: Abbot Laboratories SA/General Foundation University of Granada - Enterprise)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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