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OpenTrials
Completed

NCT Number: NCT00498030

Predicting Insulin Resistance in American Indian Youth

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.

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Key information

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rosebud Indian Reservation

Rosebud, South Dakota, 57570, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Change in Insulin Resistance

    Time frame: one year

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

Secondary outcomes

  1. Changes in Body Mass Index (BMI)

    Time frame: One year

    To determine if BMI is a good marker for insulin resistance and if BMI changes after enrollment in diabetes intervention program.

  2. Change in Fasting Lipids

    Time frame: One year

    To determine if fasting lipids levels are a good marker for insulin resistance and if fasting lipid levels change after enrollment in diabetes intervention program.

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Collaborators

  • Indian Health Service (IHS)

Registry information

Important dates

Study start
2005
Primary completion
2018
Study completion
2018
First posted
Jul 9, 2007
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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