Insulin Resistance and Cognitive Dysfunction in Obese Adolescents: Pilot Study
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Program
Sponsored by
About this trial
This is an interventional supportive care trial for Obesity
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.
Sites / Locations
- Winthrop University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Exercise Program upon enrollment
Exercise Program 6 months after enrollment
Arm Description
Subject will receive exercise intervention immediately upon enrollment to study
Subject will be enrolled into study and then receive exercise intervention 6 months after enrollment.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01737658
Brief Title
Insulin Resistance and Cognitive Dysfunction in Obese Adolescents: Pilot Study
Official Title
Insulin Resistance and Cognitive Dysfunction in Obese Adolescents: Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise Program upon enrollment
Arm Type
Other
Arm Description
Subject will receive exercise intervention immediately upon enrollment to study
Arm Title
Exercise Program 6 months after enrollment
Arm Type
Other
Arm Description
Subject will be enrolled into study and then receive exercise intervention 6 months after enrollment.
Intervention Type
Other
Intervention Name(s)
Exercise Program
Intervention Description
Exercise Program for Obese Adolescents
Primary Outcome Measure Information:
Title
Formal exercise intervention and cognitive dysfunction in obeses adolescents
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Systemic and Cognitive effects of adding exercise program to obese adolescent's lifestyle.
Description
To assess the physical fitness among participating children and adolescents before and after completion of the exercise program.
Time Frame
1 year
Title
Systemic and Cognitive effects of adding exercise program to obese adolescent's lifestyle.
Description
To evaluate the change in insulin sensitivity and neurocognitive function among participating children and adolescents before and after completion of the exercise program.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siham Accacha, MD
Organizational Affiliation
Winthrop University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Insulin Resistance and Cognitive Dysfunction in Obese Adolescents: Pilot Study
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