Predicting Insulin Resistance in American Indian Youth

Completed

• Conditions: Insulin Resistance; Stress, Psychological

• Registration Number: NCT00498030
• Lead Sponsor: University of Nebraska

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2005-12-05
• Study First Submitted: 2007-07-06
• Study First Submitted QC: 2007-07-06
• Study First Posted: 2007-07-09
• Primary Completion: 2018-03-29
• Study Completion: 2018-03-29
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-25
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Insulin Resistance	one year	This study will assess for change in insulin resistance in Native American Children over one year.

Secondary Outcome Measures

Name	Time	Method
Changes in Body Mass Index (BMI)	One year	To determine if BMI is a good marker for insulin resistance and if BMI changes after enrollment in diabetes intervention program.
Change in Fasting Lipids	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.

Trial Locations

Locations (1)

Rosebud Indian Reservation; 🇺🇸 Rosebud, South Dakota, United States