Clinical trial NCT00498030: Predicting Insulin Resistance in American Indian Youth
Official title: Predicting Insulin Resistance in American Indian Youth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insulin Resistance
Stress, Psychological
Keywords: Insulin Resistance
Stress, Psychological
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: Indian Health Service (IHS)
First posted: 2007-07-09
Enrollment: 202
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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.

Primary outcomes:
measure: Change in Insulin Resistance
timeFrame: one year
Secondary outcomes:
measure: Changes in Body Mass Index (BMI)
timeFrame: One year
measure: Change in Fasting Lipids
timeFrame: One year
Other outcomes:
Locations:
city: Rosebud
country: United States
facility: Rosebud Indian Reservation
state: South Dakota
Study officials:
affiliation: University of Nebraska
name: Jennifer Larsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.