Predicting Insulin Resistance in American Indian Youth

Insulin Resistance Clinical Trial

Official title:

Predicting Insulin Resistance in American Indian Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00498030
• Other study ID #: 0453-04-FB
• Secondary ID: U26IHS300002/01
• Status: Completed
• Start date: December 5, 2005
• Est. completion date: March 29, 2018

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: March 29, 2018
• Est. primary completion date: March 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insulin Resistance
• Stress, Psychological

Locations

Country	Name	City	State
United States	Rosebud Indian Reservation	Rosebud	South Dakota

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska	Indian Health Service (IHS)

Country where clinical trial is conducted

United States, 

References & 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. 201 — View 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/ — View 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. Epu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Insulin Resistance	This study will assess for change in insulin resistance in Native American Children over one year.	one year
Secondary	Changes in Body Mass Index (BMI)	To determine if BMI is a good marker for insulin resistance and if BMI changes after enrollment in diabetes intervention program.	One year
Secondary	Change in Fasting Lipids	To determine if fasting lipids levels are a good marker for insulin resistance and if fasting lipid levels change after enrollment in diabetes intervention program.	One year