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Vyvanse and Glucose Intolerance in Children With ADHD and Obesity

This study is currently Recruiting

June 2011 By Duke University

First Recieved on November 19, 2009

Last Updated on June 12, 2011

Sponsor: Duke University
Collaborators: Shire Pharmaceutical Development
Information provided by: Duke University
Identifier: NCT01017263

Purpose

The purpose of this study to assess the effects of chronic administration of Vyvanse (lis-dexamphetamine) on glucose metabolism in a sample of children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD) who also have glucose intolerance and are obese.

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:8 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:Accepts Healthy Volunteers
Criteria

Inclusion Criteria: - male or female, ages between 8 and 17 - Body Mass Index > 30 - fasting blood sugar between 90-100 mg/dl - 2 hour post prandial >140 <180 mg/dl - meets criteria for a diagnosis of ADHD, any subtype Exclusion Criteria: - known cardiovascular disease or diabetes - structural cardiac abnormalities, abnormal ECGs, family history of sudden death - positive urine drug screen - fasting blood sugar level > 126 mg/dl - HbA1c > 6.5 % - Weight > 300 lbs

Investigators

  • Investigator: Scott H Kollins, PhD - Principal Investigator - Duke University

Locations

  • Duke Child and Family Study Center

    Durham, North Carolina 27705 United States

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