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临床试验/NCT00498030
NCT00498030已完成不适用

Predicting Insulin Resistance in American Indian Youth

University of Nebraska1 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2005年12月5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
202
试验地点
1
主要终点
Change in Insulin Resistance

研究概览

简要总结

The purpose of this study is to identify risks that may contribute to increased insulin resistance which may help explain some of the increased incidence of type 2 diabetes in American Indian Youth, at the Rosebud reservation ages 5 to 18 years old. If specific positive indicators of insulin resistance are present, individuals are recruited back in one year for repeat of all measures.

详细描述

Type 2 diabetes is rapidly becoming more prevalent in the United States but especially among minority populations at a younger age. Identification of risk factors, including traditional risk factors such as increased BMI, lack of exercise, increased glucose in the diet, higher blood pressure and lipids, along with other factors such as chronic stress, use of alcohol or other drugs has not previously been done with minority youth. If risk factors can be identified, more strategies for prevention of diabetes can be developed that specifically target this population. This study will enroll 300 Native American Youth over a 4 year period and perform body measurements including height, weight, waist circumference, blood pressure and lab values including a 2hour glucose tolerance test, fasting lipids, and a urine albumin creatinine ratio test. In addition, subjects will be asked to identify behavior and feelings of stress in everyday lives. Subjects who are determined to be at increased risk of developing diabetes will be asked to repeat the tests in one year. The results will be reported to the tribal council to help determine prevention strategies.

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

入选标准

  • Native American youth between ages of 5 and 18 who are eligible for health care at Rosebud Sioux Reservation (Rosebud, SD) and willing to be measured and participate in a 2 hour glucose tolerance test and who have parental consent.

排除标准

  • Those who have diabetes previously identified or those with chronic steroid use, or identified conditions that affect weight balance such as cancer.

结局指标

主要结局

Change in Insulin Resistance

时间窗: one year

This study will assess for change in insulin resistance in Native American Children over one year.

次要结局

  • Changes in Body Mass Index (BMI)(One year)
  • Change in Fasting Lipids(One year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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