跳至主要内容
临床试验/NCT00339482
NCT00339482已完成不适用

Prospective Studies of Diabetes Mellitus and Its Complications in the Gila River Indian Community

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)1 个研究点 分布在 1 个国家目标入组 12,647 人开始时间: 2006年6月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12,647
试验地点
1
主要终点
To investigate the determinants of type 2 diabetes and its complications.

研究概览

简要总结

This project is a continuation of an extensive longitudinal population-based epidemiological investigation of the etiology and determinants of type 2 diabetes (and its complications) and formerly arthritis. The original baseline observations were made on the residents of the Gila Indian Reservation, predominantly Pima Indians, in 1965. We attempt to reexamine the population at two-yearly intervals, and have continued to recruit new respondents who, because of age and residence or familial relationships, become eligible for entry into the project. Eligible persons receive a battery of standardized examinations related to diabetes and its complications at two-yearly intervals, including a glucose tolerance test, biochemical determinations, such as serum cholesterol and creatinine, insulin, etc., a physical examination, and in those aged 15 years and above, retinal photographs, and an electrocardiogram. Persons known to have diabetes will be asked to undergo the examination at annual intervals to enable more complete and accurate documentation of their health status and to identify the development and progression of complications of the disease.

The data collected have been used to describe the natural history and determinants of diabetes and its complications, to investigate factors relating to the etiology of these diseases and investigate the genetics of diabetes, its complications and other phenotypes. In addition, the project serves to identify subjects with specific characteristics for the clinical research projects carried out by the Obesity and Diabetes Clinical Research Section and the Diabetes Epidemiology and Clinical Research Section fo the Branch.

详细描述

This project is a continuation of an extensive longitudinal population-based epidemiological investigation of the etiology and determinants of type 2 diabetes (and its complications) and formerly arthritis. The original baseline observations were made on the residents of the Gila Indian Reservation, predominantly Pima Indians, in 1965. We attempt to reexamine the population at two-yearly intervals, and have continued to recruit new respondents who, because of age and residence or familial relationships, become eligible for entry into the project. Eligible persons receive a battery of standardized examinations related to diabetes and its complications at two-yearly intervals, including a glucose tolerance test, biochemical determinations, such as serum cholesterol and creatinine, insulin, etc., a physical examination, and in those aged 15 years and above, retinal photographs, and an electrocardiogram. Persons known to have diabetes will be asked to undergo the examination at annual intervals to enable more complete and accurate documentation of their health status and to identify the development and progression of complications of the disease.

The data collected have been used to describe the natural history and determinants of diabetes and its complications, to investigate factors relating to the etiology of these diseases and investigate the genetics of diabetes, its complications and other phenotypes. In addition, the project serves to identify subjects with specific characteristics for the clinical research projects carried out by the Obesity and Diabetes Clinical Research Section and the Diabetes Epidemiology and Clinical Research Section of the Branch.

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
5 Years 至 99 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The study population is all persons aged 5 years and over residing on the Gila River Indian Reservation in Arizona. The vast majority of the eligible subjects are American Indians and there are similar numbers of males and females in the population. The study population was chosen because our previous work has shown that this population has the highest prevalence of Type 2 diabetes in the world. There are small numbers of other racial groups in the selected population who are also eligible to participate in the study. They are mainly members of the families in the community and therefore by participating they can contribute valuable research information to the study. All persons resident in the community aged 5 years and over are invited to participate in the study at two-yearly intervals. In addition, other tribal members and selected family members such as first or second degree relatives of the study population who reside, or have moved off the Reservation, are also eligible to participate.

排除标准

  • 未提供

研究组 & 干预措施

American Indians

Residents of the Gila River Indian Community

结局指标

主要结局

To investigate the determinants of type 2 diabetes and its complications.

时间窗: indefinite

Development of diabetes and related complications.

次要结局

未报告次要终点

研究者

研究点 (1)

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