Clinical trial NCT01634464: Role of Nutrition and Maternal Genetics on the Programming of Development of Fetal Adipose Tissue
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Diabetes
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: Ministerio de Economía y Competitividad, Spain
name: Abbott
name: Scottish Government NuGO EU Project
name: University of Barcelona
name: ICTAN-CSIC - Madrid - Spain
name: Ludwig-Maximilians - University of Munich
name: University of Nottingham
name: University of Aberdeen
name: Andalusian Agency of Knowledge
First posted: 2012-07-06
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Long-term evidence of early human programming of obesity measured by nutritional biomarkers, and the offspring growth and development.
timeFrame: Participants will be followed for the duration of the study, an expected average of 6 years
measure: Long-term evidence of early human programming of obesity measured by genetic biomarkers, and the offspring growth and development.
timeFrame: Participants will be followed for the duration of the study, an expected average of 6 years
measure: Long-term evidence of early human programming of obesity measured biochemical perinatal biomarkers, and the offspring growth and development.
timeFrame: Participants will be followed for the duration of the study, an expected average of 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Department of Pediatrics, School of Medicine, University of Granada
Study officials:
affiliation: Universidad de Granada
name: Cristina Campoy, Professor, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.