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Sponsors and Collaborators: |
University of Nebraska Indian Health Service (IHS) |
Information provided by: | University of Nebraska |
ClinicalTrials.gov Identifier: | NCT00498030 |
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.
Condition |
Insulin Resistance Stress, Psychological |
MedlinePlus related topics: | Stress |
ChemIDplus related topics: | Insulin |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Predicting Insulin Resistance in American Indian Youth |
Samples are only retained until specific tests are completed. Some tests are done in the clinical lab and some tests are done in the research lab.
Estimated Enrollment: | 300 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | September 2009 |
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.
Ages Eligible for Study: | 5 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
Exclusion Criteria:
Contact: Mary Whiting | 605-747-4600 | mwhiting@unmc.edu |
United States, South Dakota | |||||
Rosebud Indian Reservation | Recruiting | ||||
Rosebud, South Dakota, United States, 57570 | |||||
Contact: Mary Whiting 605-747-4600 |
University of Nebraska |
Indian Health Service (IHS) |
Principal Investigator: | Jennifer Larsen, M.D. | University of Nebraska |
Responsible Party: | University of Nebraska Medical Center ( Dr. Jennifer Larsen ) |
Study ID Numbers: | IRB#453-04, U26IHS300002/01 |
First Received: | July 6, 2007 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00498030 |
Health Authority: | United States: Institutional Review Board |
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