Insulin Resistance and Cognitive Dysfunction in Obese Adolescents: Pilot Study

NCT ID: NCT01737658

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2016-02-29

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Exercise Program upon enrollment

Subject will receive exercise intervention immediately upon enrollment to study

Group Type: OTHER

Exercise Program

Intervention Type: OTHER

Exercise Program for Obese Adolescents

Exercise Program 6 months after enrollment

Subject will be enrolled into study and then receive exercise intervention 6 months after enrollment.

Group Type: OTHER

Exercise Program

Intervention Type: OTHER

Exercise Program for Obese Adolescents

Interventions

Exercise Program

Exercise Program for Obese Adolescents

Intervention Type: OTHER

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Siham Accacha, MD

Role: PRINCIPAL_INVESTIGATOR

Winthrop University Hospital

Locations

Winthrop University Hospital

Mineola, New York, United States

Countries

United States

Other Identifiers

12041

Identifier Type: -

Identifier Source: org_study_id