Predicting Insulin Resistance in American Indian Youth

NCT ID: NCT00498030

Last Updated: 2023-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

202 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-12-05

Study Completion Date

2018-03-29

Brief Summary

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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

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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.

Conditions

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Insulin Resistance Stress, Psychological

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Indian Health Service (IHS)

FED

Sponsor Role collaborator

University of Nebraska

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer Larsen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

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Rosebud Indian Reservation

Rosebud, South Dakota, United States

Site Status

Countries

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United States

References

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Nsiah-Kumi PA, Beals J, Lasley S, Whiting M, Brushbreaker C, Erickson J, Qiu F, Yu F, Canaris G, Larsen JL. Body mass index percentile more sensitive than acanthosis nigricans for screening Native American children for diabetes risk. J Natl Med Assoc. 2010 Oct;102(10):944-9. doi: 10.1016/s0027-9684(15)30714-8.

Reference Type RESULT
PMID: 21053710 (View on PubMed)

Nsiah-Kumi PA, Lasley S, Whiting M, Brushbreaker C, Erickson JM, Qiu F, Yu F, Larsen JL. Diabetes, pre-diabetes and insulin resistance screening in Native American children and youth. Int J Obes (Lond). 2013 Apr;37(4):540-5. doi: 10.1038/ijo.2012.199. Epub 2012 Dec 11.

Reference Type RESULT
PMID: 23229738 (View on PubMed)

Nsiah-Kumi PA, Erickson JM, Beals JL, Ogle EA, Whiting M, Brushbreaker C, Borgeson CD, Qiu F, Yu F, Larsen JL. Vitamin D insufficiency is associated with diabetes risk in Native American children. Clin Pediatr (Phila). 2012 Feb;51(2):146-53. doi: 10.1177/0009922811417290. Epub 2011 Oct 20.

Reference Type RESULT
PMID: 22019791 (View on PubMed)

Other Identifiers

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U26IHS300002/01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

0453-04-FB

Identifier Type: -

Identifier Source: org_study_id

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