跳至主要内容
临床试验/NCT01316783
NCT01316783Enrolling By Invitation不适用

Genetics of Obesity, Diabetes, and Heart Disease in African Diaspora Populations

National Human Genome Research Institute (NHGRI)1 个研究点 分布在 1 个国家目标入组 1,100 人开始时间: 2011年5月6日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
1,100
试验地点
1
主要终点
Metabolic disorders

研究概览

简要总结

Background:

- African Americans have one of the highest rates of type 2 diabetes in the United States, and often have other medical problems related to obesity and cardiovascular disease. These conditions have various risk factors, including high blood sugar levels, high cholesterol levels, and insulin resistance. However, these risk factors have not been studied very closely in individuals with African ancestry, including Afro-Caribbean and sub-Saharan Africa migrant populations. Researchers are interested in conducting a genetic study on obesity, adult-onset diabetes, heart disease, and other common health conditions in individuals with African ancestry.

Objectives:

- To collect genetic and non-genetic information from individuals with African ancestry to study common health conditions related to obesity, adult-onset diabetes, and heart disease.

Eligibility:

- Individuals at least 18 years of age who self-identify as African American, Afro-Caribbean, or migrants from sub Saharan Africa.

Design:

  • Participants will undergo a physical examination and will provide a blood sample for study.
  • Participants will also answer questions about personal and family medical history and current lifestyle behaviors.
  • No treatment will be provided as part of this protocol.

详细描述

Study Description:

The study is to perform a quantitative trait analysis of multiple metabolic biomarkers and disorders including T2D, hypertension, CVD and obesity in a total of 1000 people of African ancestry and approximately 100 whites (who will serve as a comparison group) residing in the United States.

We will also perform exome sequencing of 48 cases of African descent and genotype identified variants in the larger cohort. Cases for exome sequencing will consist of individuals who have more than one metabolic condition, i.e., diabetes, pre-diabetes, obesity, hypertension and/or dyslipidemia. We propose to carry out exome capture of 48 individuals (96 chromosomes).

Objectives:

Primary Objective: Genotype variants of interest from genetic epidemiology studies conducted in Dr. Rotimi's lab in these individuals, with thorough clinical measurements available, in order to investigate biological mechanisms underlying observed associations.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • INCLUSION CRITERIA:
  • Subjects will include unrelated persons who self-identify as white or African American, Afro-Caribbean or migrant from sub-Saharan Africa. Adults of African ancestry are prioritized for this study because of the paucity of genetics studies investigating the association of risk alleles contributing to the prevalence of T2D, CVD, obesity and other common conditions in this population. A small proportion of whites (less than 10%) will be included in this study, as they are in Dr. Sumner's ongoing projects; they will have the same clinical measurements obtained in the same laboratory to serve as a comparison group. This study only includes adults because these phenotypes are more commonly present in adults. In summary, inclusion criteria include:
  • Persons who self-identify as either
  • African American
  • Afro-Caribbean
  • A migrant from sub-Saharan Africa
  • Persons >= 18 years
  • Participation in a protocol with Dr. Anne Sumner, NIDDK

排除标准

  • Related individuals are excluded to avoid biases in our analyses due to genomic similarities between people who are related. Adults unable to consent will be included in this study. Pregnant women are excluded from this study because pregnancy induces changes in metabolism that would interfere with the measurements and outcomes of the study. In summary, exclusion criteria include:
  • Individuals related to participants (any known familial relationship, as reported by the prospective enrollee)
  • Adults unable to consent
  • Pregnant women

研究组 & 干预措施

Healthy Volunteers

African ancestry and whites (who will serve as a comparison group)

结局指标

主要结局

Metabolic disorders

时间窗: One study visit

type 2 diabetes, metabolic outcomes, dyslipidemia

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Genetics of Obesity, Diabetes, and Heart Disease in... | 临床试验