跳至主要内容
临床试验/NCT04621396
NCT04621396招募中不适用

Genetic and Environmental Influences on Development of Type 2 Diabetes in Childhood: The Next Generation Longitudinal Birth Cohort.

University of Manitoba2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2013年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
600
试验地点
2
主要终点
Obesity

研究概览

简要总结

The overall aim of this project is to understand the independent roles of maternal factors, intrauterine exposures, genetic factors, and postnatal environment on the development of obesity and youth-onset type 2 diabetes (T2D) in childhood.

详细描述

Our primary objective for the study is to clinically and metabolically phenotype parents and their offspring to identify risk factors for obesity, T2D, and cardiometabolic risk in childhood and adolescence in a prospective birth cohort by reporting:

  1. Maternal and/or paternal factors including anthropometrics, metabolic parameters, HNF1a genotype, lifestyle (diet and physical activity), and socioeconomic environment.
  2. Infant factors including anthropometrics, early infant nutrition, and metabolism.

Secondary Objectives:

  1. To evaluate if children born to mothers with T2D prior o pregnancy are at increased risk of obesity and T2D.
  2. To determine the modifiable risk factors which contribute to the increased risk of obesity and T2D.
  3. To evaluate the differential risk between mothers and fathers with T2D in terms of somatic and genetic contributions to risk compared to intrauterine environmental contributions to risk.
  4. To plan a large-scale, randomized, controlled community-based breastfeeding intervention with intensive breastfeeding counseling and support for the prevention of T2D development in offspring of mothers or fathers with youth onset T2D.
  5. To explore potential new research questions and feasibility studies for epigenetic studies using cord blood under the umbrella of the new research theme on T2D at the Children's Hospital Research Institute of Manitoba.

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
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Pregnant women with type 2 diabetes, gestational diabetes, or no diabetes.
  • From self-identified Indigenous heritage (e.g., Cree, Oji-Cree, Métis, Anishinaabe, etc.).
  • Are delivering and residing in Manitoba.
  • Mother/Father and children must be biological family members.

排除标准

  • Mothers or children with type 1 diabetes.
  • Residing outside of Manitoba.

研究组 & 干预措施

Next Generation Cohort

We will follow the children from mothers who either have T2D, GDM, or are controls.

干预措施: Observational screening study (Other)

结局指标

主要结局

Obesity

时间窗: 18 years

Development of obesity defined by the International task force on obesity cut offs for age and gender.

Type 2 Diabetes

时间窗: 18 years

Development of type 2 diabetes defined by diagnostic criteria in the Canadian Diabetes association 2008 guidelines in childhood (≤ 7 years) or adolescence (12-16 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

Dr. Brandy Wicklow

Assistant Professor, Pediatrics and Child Health

University of Manitoba

研究点 (2)

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