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Insulin Resistance and Cognitive Dysfunction in Obese Adolescents: Pilot Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01737658
First Posted: November 29, 2012
Last Update Posted: January 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Siham Accacha, MD, Winthrop University Hospital
  Purpose
Obese Adolescents will be evaluated for insulin resistance and cognitive dysfunction.

Condition Intervention
Obesity Other: Exercise Program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Insulin Resistance and Cognitive Dysfunction in Obese Adolescents: Pilot Study

Resource links provided by NLM:


Further study details as provided by Siham Accacha, MD, Winthrop University Hospital:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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.


Enrollment: 56
Study Start Date: December 2012
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Exercise Program upon enrollment
Subject will receive exercise intervention immediately upon enrollment to study
Other: Exercise Program
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.
Other: Exercise Program
Exercise Program for Obese Adolescents

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01737658


Locations
United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
Sponsors and Collaborators
Winthrop University Hospital
Investigators
Principal Investigator: Siham Accacha, MD Winthrop University Hospital
  More Information

Responsible Party: Siham Accacha, MD, Pediatric Endocrinology and Metabolism; Assistant Professor Stoney Brook School of Medicine; Principal Investigator, Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT01737658     History of Changes
Other Study ID Numbers: accacha01
First Submitted: November 5, 2012
First Posted: November 29, 2012
Last Update Posted: January 10, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Insulin Resistance
Cognitive Dysfunction
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders