Predicting Insulin Resistance in American Indian Youth

This study has been completed.
Sponsor:
Collaborator:
Indian Health Service (IHS)
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00498030
First received: July 6, 2007
Last updated: April 14, 2010
Last verified: April 2010
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predicting Insulin Resistance in American Indian Youth

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

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.


Enrollment: 202
Study Start Date: December 2005
Study Completion Date: November 2009
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.

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00498030

Locations
United States, South Dakota
Rosebud Indian Reservation
Rosebud, South Dakota, United States, 57570
Sponsors and Collaborators
University of Nebraska
Indian Health Service (IHS)
Investigators
Principal Investigator: Jennifer Larsen, M.D. University of Nebraska
  More Information

No publications provided

Responsible Party: Dr. Jennifer Larsen, University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT00498030     History of Changes
Other Study ID Numbers: 453-04, U26IHS300002/01
Study First Received: July 6, 2007
Last Updated: April 14, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
Insulin Resistance
Stress, Psychological

Additional relevant MeSH terms:
Insulin Resistance
Stress, Psychological
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Behavioral Symptoms
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014