Predicting Insulin Resistance in American Indian Youth

NCT00498030 | Completed DMC

• 2 other identifiers: 0453-04-FBU26IHS300002/01
• Study Type: observational
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Resistance; Stress, Psychological

Keywords

Insulin Resistance; Stress, Psychological

Outcome Measures

Primary Outcomes (1)

• Change in Insulin Resistance

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

  one year

Secondary Outcomes (2)

• Changes in Body Mass Index (BMI)

  One year

• Change in Fasting Lipids

  One year

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Nebraska: lead
• Indian Health Service (IHS): collaborator

Study Sites (1)

Rosebud Indian Reservation

Rosebud, South Dakota, 57570, United States

Location

Related Publications (3)

• 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.

  PMID: 21053710 RESULT

• 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.

  PMID: 23229738 RESULT

• 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.

  PMID: 22019791 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

Insulin Resistance; Stress, Psychological

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavioral Symptoms; Behavior

Study Officials

• Jennifer Larsen, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2007
• First Posted: July 9, 2007
• Study Start: December 5, 2005
• Primary Completion: March 29, 2018
• Study Completion: March 29, 2018
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

US (1)