Role of Nutrition and Maternal Genetics on the Programming of Development of Fetal Adipose Tissue (PREOBE)
5. juli 2012 opdateret af: 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).
Studieoversigt
Undersøgelsestype
Observationel
Tilmelding (Forventet)
300
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Granada, Spanien, 18012
- Rekruttering
- Department of Pediatrics, School of Medicine, University of Granada
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Kontakt:
- Cristina Campoy, Professor, MD
- Telefonnummer: 0034 629308695
- E-mail: ccampoy@ugr.es
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 42 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Control group
women with 18.5 > BMI < 25
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Pregnant women with overweight
BMI≥25 before the pregnancy
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Pregnant women with obesity
BMI≥30 before the pregnancy
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Pregnant women with gestational diabetes
Gestational diabetes
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Long-term evidence of early human programming of obesity measured by nutritional biomarkers, and the offspring growth and development.
Tidsramme: Participants will be followed for the duration of the study, an expected average of 6 years
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Participants will be followed for the duration of the study, an expected average of 6 years
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Long-term evidence of early human programming of obesity measured by genetic biomarkers, and the offspring growth and development.
Tidsramme: Participants will be followed for the duration of the study, an expected average of 6 years
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Participants will be followed for the duration of the study, an expected average of 6 years
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Long-term evidence of early human programming of obesity measured biochemical perinatal biomarkers, and the offspring growth and development.
Tidsramme: Participants will be followed for the duration of the study, an expected average of 6 years
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Participants will be followed for the duration of the study, an expected average of 6 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Cristina Campoy, Professor, MD, Universidad de Granada
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2007
Primær færdiggørelse (Faktiske)
1. oktober 2010
Studieafslutning (Forventet)
1. juni 2013
Datoer for studieregistrering
Først indsendt
19. marts 2012
Først indsendt, der opfyldte QC-kriterier
2. juli 2012
Først opslået (Skøn)
6. juli 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
9. juli 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. juli 2012
Sidst verificeret
1. juli 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- P06-CTS-02341
- 334602 Preobe Follow Up (Andet bevillings-/finansieringsnummer: Abbot Laboratories SA/General Foundation University of Granada - Enterprise)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .