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临床试验/NCT01634464
NCT01634464Unknown不适用

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

Universidad de Granada1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2007年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
Long-term evidence of early human programming of obesity measured by nutritional biomarkers, and the offspring growth and development.

研究概览

简要总结

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Long-term evidence of early human programming of obesity measured by nutritional biomarkers, and the offspring growth and development.

时间窗: 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.

时间窗: 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.

时间窗: Participants will be followed for the duration of the study, an expected average of 6 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cristina Campoy

Professor

Universidad de Granada

研究点 (1)

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