Impaired Glucose Tolerance Clinical Trial
Official title:
Prevention of Type 2 Diabetes in Children With a Family-based Healthy Lifestyle Program
Verified date | June 2014 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The purpose of this study is to determine if the Bright Bodies (BB) Healthy Lifestyle Program can help reverse early abnormalities in glucose metabolism and prevent the progression to type 2 diabetes (T2DM) in high-risk, obese youth with newly-diagnosed impaired glucose tolerance (IGT).
Status | Completed |
Enrollment | 72 |
Est. completion date | September 2011 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 11 Years to 16 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of IGT (glucose 140-199 at 2 hrs during OGTT) - Age 11 to 16 - An interest in being enrolled in a healthy lifestyle program - A parent/caregiver willing to participate with child in program Exclusion Criteria: - Psychiatric disorder or serious medical condition that would preclude participation in program - Currently taking medication that potentially effects insulin sensitivity (eg Metformin) or causes weight gain (example: Risperidone) or weight loss (eg Xenical) - Involvement in co-existing weight management/healthy lifestyle program - Plans of moving out of the Greater New Haven area within six months |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Yale Center for Clinical Investigation | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | National Center for Research Resources (NCRR), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 2-hour plasma glucose, category of glucose tolerance (IGT, NGT, T2DM) | 6 months | No | |
Secondary | Homeostasis model assessment of insulin resistance (HOMA-IR) | 6 months | No | |
Secondary | Lipid profile | 6 months | No | |
Secondary | Alanine aminotransferase (ALT) | 6 months | No | |
Secondary | Body mass index (BMI) | 6 months | No | |
Secondary | Body fat mass and % | 6 months | No | |
Secondary | Blood pressure (BP) | 6 months | No | |
Secondary | Piers-Harris Self-concept scale score | 6 months | No | |
Secondary | Child behavior checklist score | 6 months | No | |
Secondary | Family assessment device (FAD) score | 6 months | No |
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