Impaired Glucose Tolerance
Conditions
Keywords
Impaired Glucose Tolerance, PreDiabetes, Diabetes Prevention
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.
Interventions
BEHAVIORALBright Bodies Healthy Lifestyle Program
Subjects attend program with a caregiver or parent twice per week for 6 mos. Exercise is 2x/wk, behavior mod/nutrition 1 x/wk, and parent class 1 x/wk. Smart Moves curriculum is utilized for nutrition and behavior mod.
BEHAVIORALControl
Subjects will be given basic instruction by clinical provider and goals will be followed up every 3 months.
Sponsors
National Institutes of Health (NIH)
National Center for Research Resources (NCRR)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-hour plasma glucose, category of glucose tolerance (IGT, NGT, T2DM) | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Lipid profile | 6 months |
| Alanine aminotransferase (ALT) | 6 months |
| Body mass index (BMI) | 6 months |
| Body fat mass and % | 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 |
Countries
United States
Outcome results
None listed