Vyvanse and Glucose Intolerance in Children With Attention Deficit Hyperactivity Disorder (ADHD) and Obesity

• Status: Terminated
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Duke University
• Collaborator: Shire
• Treatments: Dextroamphetamine; Lisdexamfetamine Dimesylate

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