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

NCT ID: NCT01634464

Last Updated: 2012-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-03-31

Study Completion Date

2013-06-30

Brief Summary

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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

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Conditions

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Obesity Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control group

women with 18.5 \> BMI \< 25

No interventions assigned to this group

Pregnant women with overweight

BMI≥25 before the pregnancy

No interventions assigned to this group

Pregnant women with obesity

BMI≥30 before the pregnancy

No interventions assigned to this group

Pregnant women with gestational diabetes

Gestational diabetes

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

* Mothers following an extravagant diet or vegan diet.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ministerio de Economía y Competitividad, Spain

OTHER_GOV

Sponsor Role collaborator

Abbott

INDUSTRY

Sponsor Role collaborator

Scottish Government NuGO EU Project

UNKNOWN

Sponsor Role collaborator

University of Barcelona

OTHER

Sponsor Role collaborator

ICTAN-CSIC - Madrid - Spain

UNKNOWN

Sponsor Role collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role collaborator

University of Nottingham

OTHER

Sponsor Role collaborator

University of Aberdeen

OTHER

Sponsor Role collaborator

Andalusian Agency of Knowledge

OTHER_GOV

Sponsor Role collaborator

Universidad de Granada

OTHER

Sponsor Role lead

Responsible Party

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Cristina Campoy

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cristina Campoy, Professor, MD

Role: STUDY_DIRECTOR

Universidad de Granada

Locations

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Department of Pediatrics, School of Medicine, University of Granada

Granada, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Cristina Campoy, Professor, MD

Role: CONTACT

Phone: 0034 629308695

Email: [email protected]

Facility Contacts

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Cristina Campoy, Professor, MD

Role: primary

References

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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.

Reference Type RESULT
PMID: 20205964 (View on PubMed)

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.

Reference Type RESULT
PMID: 19132267 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38052208 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26931143 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26208217 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26025336 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26021978 (View on PubMed)

Other Identifiers

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334602 Preobe Follow Up

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

P06-CTS-02341

Identifier Type: -

Identifier Source: org_study_id