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Predicting Insulin Resistance in American Indian Youth

This study is currently recruiting participants.
Verified by University of Nebraska, June 2008

Sponsors and Collaborators: University of Nebraska
Indian Health Service (IHS)
Information provided by: University of Nebraska
ClinicalTrials.gov Identifier: NCT00498030
  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

MedlinePlus related topics:   Stress   

ChemIDplus related topics:   Insulin   

U.S. FDA Resources

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

Further study details as provided by University of Nebraska:

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

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

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

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

Contacts
Contact: Mary Whiting     605-747-4600     mwhiting@unmc.edu    

Locations
United States, South Dakota
Rosebud Indian Reservation     Recruiting
      Rosebud, South Dakota, United States, 57570
      Contact: Mary Whiting     605-747-4600        

Sponsors and Collaborators
University of Nebraska
Indian Health Service (IHS)

Investigators
Principal Investigator:     Jennifer Larsen, M.D.     University of Nebraska    
  More Information


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

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

Study placed in the following topic categories:
Hyperinsulinism
Metabolic Diseases
Stress, Psychological
Stress
Insulin Resistance
Metabolic disorder
Glucose Metabolism Disorders
Insulin
Behavioral Symptoms

ClinicalTrials.gov processed this record on October 06, 2008




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