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Completed

NCT Number: NCT01737658

Insulin Resistance and Cognitive Dysfunction in Obese Adolescents: Pilot Study

Obese Adolescents will be evaluated for insulin resistance and cognitive dysfunction.

Completed

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Key information

Age range

14 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Winthrop University Hospital

Mineola, New York, 11501, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

exercise program

Other

Exercise Program for Obese Adolescents

Primary outcomes

  1. Formal exercise intervention and cognitive dysfunction in obeses adolescents

    Time frame: 1 year

    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 outcomes

  1. Systemic and Cognitive effects of adding exercise program to obese adolescent's lifestyle.

    Time frame: 1 year

    To assess the physical fitness among participating children and adolescents before and after completion of the exercise program.

  2. Systemic and Cognitive effects of adding exercise program to obese adolescent's lifestyle.

    Time frame: 1 year

    To evaluate the change in insulin sensitivity and neurocognitive function among participating children and adolescents before and after completion of the exercise program.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Nov 29, 2012
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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