Prevention of Type 2 Diabetes in Children With a Family-based Healthy Lifestyle Program
- Conditions
- Impaired Glucose Tolerance
- Registration Number
- NCT01030978
- Lead Sponsor
- Yale University
- Brief Summary
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).
- Detailed Description
Primary Aim: (1) To determine whether youth randomized to the Bright Bodies (BB) Healthy Lifestyle Program have lower 2-hr plasma glucose levels than those randomized to standard lifestyle counseling (control) after 6 months.
Secondary Aims: (2) To determine if greater conversions from IGT to normal glucose tolerance (NGT) and less development of T2DM occurs for those in the BB vs Control Group; (3)To determine if there is improvement in anthropometric/metabolic parameters in BB vs Control Group; and (4) To determine if there is an improvement in psychosocial and family dynamic outcomes of the child in BB vs Control Group.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 2-hour plasma glucose, category of glucose tolerance (IGT, NGT, T2DM) 6 months
- Secondary Outcome Measures
Name Time Method Alanine aminotransferase (ALT) 6 months Homeostasis model assessment of insulin resistance (HOMA-IR) 6 months Piers-Harris Self-concept scale score 6 months Child behavior checklist score 6 months Family assessment device (FAD) score 6 months Blood pressure (BP) 6 months Lipid profile 6 months Body mass index (BMI) 6 months Body fat mass and % 6 months
Trial Locations
- Locations (1)
Yale Center for Clinical Investigation
🇺🇸New Haven, Connecticut, United States
Yale Center for Clinical Investigation🇺🇸New Haven, Connecticut, United States