Insulin Resistance and Cognitive Dysfunction in Obese Adolescents: Pilot Study

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

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: Exercise Program

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Mineola, New York, United States, 11501
      • Winthrop University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Exercise Program upon enrollment; Subject will receive exercise intervention immediately upon enrollment to study	Other: Exercise Program; Exercise Program for Obese Adolescents
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year
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.	1 year

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Siham Accacha, MD, Winthrop University Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: November 5, 2012
• First Submitted That Met QC Criteria: November 26, 2012
• First Posted (Estimate): November 29, 2012

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 13, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Neurocognitive Disorders; Hyperinsulinism; Cognition Disorders; Cognitive Dysfunction; Insulin Resistance
• Other Study ID Numbers: 12041 (Registry Identifier: DAIDS-ES Registry Number)