Insulin Resistance and Cognitive Dysfunction in Obese Adolescents: Pilot Study

Study Overview
=================
Brief Summary
-----------------
Obese Adolescents will be evaluated for insulin resistance and cognitive dysfunction.

Detailed Description
-----------------
The short-term goal of this project is to conduct a feasibility study at Winthrop University Hospital to determine how well extremely obese (BMI > 99%tile corrected for age) children and adolescents can be recruited into an exercise program and evaluated in an efficient fashion, and to identify particular strategies (e.g., medical examination feedback) that can serve as potential benefits to research subjects and their families. In addition investigators will evaluate the effect of the exercise program on physical fitness, insulin resistance, and neurocognitive functioning as well as the relationship between insulin sensitivity and neurocognitive function among adolescents who participate in the exercise program. The long-term goal of this project is to evaluate a large, multi-ethnic sample of adolescents, 14 to 19 years of age, to systematically assess cognitive function and school performance, fitness and examine the relationship between performance on those outcome variables and a variety of biomedical and psychosocial factors that may directly or indirectly influence brain function and test-taking performance. High body mass index (BMI) among children and adolescents continues to be a public health concern in the United States. The most recent figures from the National Health and Nutrition Examination Survey (NHANES) for 2007-2008 report that 18.1% (95% CI, 14.5%-21.7%) of 12- through 19-year-old adolescents were at or above the 95th percentile of BMI for age. Children with high BMI often become obese adults, and obese adults are at risk for many chronic conditions. High BMI in children may also have immediate consequences, such as elevated lipid concentrations and blood pressure. It now appears that neurocognitive dysfunction is also more common in obese children and adolescents. In a large population study of 2,519 children, 8 to 16 years of age, a brief neuropsychological assessment showed a statistically significant, albeit modest relationship between cognitive test scores and BMI that persisted after adjusting for confounding variables. Obesity is also associated with several conditions which known to affect brain function, including sleep apnea, insulin resistance, hypertension, and chronic inflammatory factors (e.g., by these variables cannot be determined, unfortunately, because those variables were not measured. It is important to note, however, that there is not complete agreement on linkages between obesity and cognition.

Official Title
-----------------
Insulin Resistance and Cognitive Dysfunction in Obese Adolescents: Pilot Study

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Other: Exercise Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subject's ages 14 to 19 years old, extremely obese (BMI ≥ 99th percentile). Clearance by pediatric cardiologist, including evaluation of V02Max. Exclusion Criteria: Male and female less than 14years of age or more than 19 years of age. Patients with type 1 or type 2 diabetes Patients with serious medical conditions. Anyone who is deemed inappropriate by pediatric cardiologist during clearance evaluation.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Exercise Program upon enrollment<br>Subject will receive exercise intervention immediately upon enrollment to study | Other: Exercise Program<br>* Exercise Program for Obese Adolescents<br>|
| Other: Exercise Program 6 months after enrollment<br>Subject will be enrolled into study and then receive exercise intervention 6 months after enrollment. | Other: Exercise Program<br>* Exercise Program for Obese Adolescents<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Formal exercise intervention and cognitive dysfunction in obeses adolescents | To measure the feasibility of recruiting extremely obese (BMI > 99%tile corrected for age) children and adolescents into an exercise program and evaluate their physical fitness. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic and Cognitive effects of adding exercise program to obese adolescent's lifestyle. | To assess the physical fitness among participating children and adolescents before and after completion of the exercise program. | 1 year | 
| Systemic and Cognitive effects of adding exercise program to obese adolescent's lifestyle. | To evaluate the change in insulin sensitivity and neurocognitive function among participating children and adolescents before and after completion of the exercise program. | 1 year |