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Insulin Resistance and Cognitive Dysfunction in Obese Adolescents: Pilot Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Winthrop University Hospital
Sponsor:
Information provided by (Responsible Party):
Siham Accacha, MD, Winthrop University Hospital
ClinicalTrials.gov Identifier:
NCT01737658
First received: November 5, 2012
Last updated: May 27, 2014
Last verified: May 2014
  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: 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 Winthrop University Hospital:

Primary Outcome Measures:
  • Formal exercise intervention and cognitive dysfunction in obeses adolescents [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To evaluate the change in insulin sensitivity and neurocognitive function among participating children and adolescents before and after completion of the exercise program.


Estimated Enrollment: 50
Study Start Date: December 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (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

Ages Eligible for Study:   14 Years to 19 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01737658

Contacts
Contact: Siham Accacha, MD 516-663-3150 saccacha@winthrop.org
Contact: Ann Mock, RN 516-663-9619 amock@winthrop.org

Locations
United States, New York
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Ann Mock, RN CCRC    516-663-9619    amock@winthrop.org   
Principal Investigator: Siham Accacha, MD         
Sub-Investigator: Jorge Corletto, MD         
Sub-Investigator: Edith Fiore, MS RN CPNP         
Sponsors and Collaborators
Winthrop University Hospital
Investigators
Principal Investigator: Siham Accacha, MD Winthrop University Hospital
  More Information

No publications provided

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
Study First Received: November 5, 2012
Last Updated: May 27, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cognition Disorders
Insulin Resistance
Delirium, Dementia, Amnestic, Cognitive Disorders
Glucose Metabolism Disorders
Hyperinsulinism
Mental Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 23, 2014