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

NCT01634464 | Unknown

• 2 other identifiers: P06-CTS-02341334602 Preobe Follow Up
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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).

Conditions

Obesity; Diabetes

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• 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 following an extravagant diet or vegan diet.

Sponsors & Collaborators

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

Study Sites (1)

Department of Pediatrics, School of Medicine, University of Granada

Granada, 18012, Spain

RECRUITING

Related Publications (7)

• Santacruz A, Collado MC, Garcia-Valdes L, Segura MT, Martin-Lagos JA, Anjos T, Marti-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 Nutr. 2010 Jul;104(1):83-92. doi: 10.1017/S0007114510000176. Epub 2010 Mar 8.

  PMID: 20205964 RESULT

• Campoy C, Martin-Bautista E, Garcia-Valdes L, Florido J, Agil A, Lorente JA, Marcos A, Lopez-Sabater MC, Miranda-Leon T, Sanz Y, Molina-Font JA; grupo PREOBE. [Study of maternal nutrition and genetic on the foetal adiposity programming (The PREOBE study)]. Nutr Hosp. 2008 Nov-Dec;23(6):584-90. Spanish.

  PMID: 19132267 RESULT

• Cerdo T, Ruiz-Rodriguez A, Acuna I, Torres-Espinola FJ, Menchen-Marquez S, Gamiz F, Gallo M, Jehmlich N, Haange SB, von Bergen M, Campoy C, Suarez A. Infant gut microbiota contributes to cognitive performance in mice. Cell Host Microbe. 2023 Dec 13;31(12):1974-1988.e4. doi: 10.1016/j.chom.2023.11.004. Epub 2023 Dec 4.

  PMID: 38052208 DERIVED

• Berglund SK, Garcia-Valdes L, Torres-Espinola FJ, Segura MT, Martinez-Zaldivar C, Aguilar MJ, Agil A, Lorente JA, Florido J, Padilla C, Altmae S, Marcos A, Lopez-Sabater MC, Campoy C; PREOBE team. Maternal, fetal and perinatal alterations associated with obesity, overweight and gestational diabetes: an observational cohort study (PREOBE). BMC Public Health. 2016 Mar 1;16:207. doi: 10.1186/s12889-016-2809-3.

  PMID: 26931143 DERIVED

• Torres-Espinola FJ, Berglund SK, Garcia-Valdes LM, Segura MT, Jerez A, Campos D, Moreno-Torres R, Rueda R, Catena A, Perez-Garcia M, Campoy C; PREOBE team. Maternal Obesity, Overweight and Gestational Diabetes Affect the Offspring Neurodevelopment at 6 and 18 Months of Age--A Follow Up from the PREOBE Cohort. PLoS One. 2015 Jul 24;10(7):e0133010. doi: 10.1371/journal.pone.0133010. eCollection 2015.

  PMID: 26208217 DERIVED

• Torres-Espinola FJ, Altmae S, Segura MT, Jerez A, Anjos T, Chisaguano M, Carmen Lopez-Sabater M, Entrala C, Alvarez JC, Agil A, Florido J, Catena A, Perez-Garcia M, Campoy C. Maternal PPARG Pro12Ala polymorphism is associated with infant's neurodevelopmental outcomes at 18 months of age. Early Hum Dev. 2015 Aug;91(8):457-62. doi: 10.1016/j.earlhumdev.2015.05.001. Epub 2015 May 26.

  PMID: 26025336 DERIVED

• Uhl O, Demmelmair H, Segura MT, Florido J, Rueda R, Campoy C, Koletzko B. Effects of obesity and gestational diabetes mellitus on placental phospholipids. Diabetes Res Clin Pract. 2015 Aug;109(2):364-71. doi: 10.1016/j.diabres.2015.05.032. Epub 2015 May 16.

  PMID: 26021978 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Maternal blood and blood from the umbilical cord, serum, plasma, placental tissue, placental tissue treated with RNAlater, saliva, oral mucosa, urine, faeces, human milk

MeSH Terms

Conditions

Obesity; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Cristina Campoy, Professor, MD

  Universidad de Granada

  STUDY DIRECTOR

Central Study Contacts

Cristina Campoy, Professor, MD

CONTACT

0034 629308695; ccampoy@ugr.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 19, 2012
• First Posted: July 6, 2012
• Study Start: March 1, 2007
• Primary Completion: October 1, 2010
• Study Completion: June 1, 2013
• Last Updated: July 9, 2012

Record last verified: 2012-07

Locations

ES (1)