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

Study Overview
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Brief Summary
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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.

Official Title
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Vyvanse and Glucose Intolerance in Children With ADHD and Obesity

Conditions
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Attention Deficit Hyperactivity Disorder, Glucose Intolerance, Obesity

Intervention / Treatment
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* Drug: Lis-dexamphetamine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Open label Vyvanse<br>Eligible subjects will be dispensed open label LDX (VyvanseTM). All subjects will start at 20 mg once a day dose and will be titrated up weekly by 10 mg increments up to a maximum dose of 70 mg. If a subject experiences intolerable side effects at a particular dose, a step down to the next tolerated level is allowed. | Drug: Lis-dexamphetamine<br>* Eligible subjects will be dispensed open label LDX (VyvanseTM). All subjects will start at 20 mg once a day dose and will be titrated up weekly by 10 mg increments up to a maximum dose of 70 mg. If a subject experiences intolerable side effects at a particular dose, a step down to the next tolerated level is allowed.<br>* Other names: Vyvanse, LDX;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre and Post Study Fasting Blood Sugar and Two Hour Post Prandial. | The study was terminated due to lack of enrollment therefore outcome measures were not assessed. If completed, the expected outcomes would have shown an improvement of the subject's fasting and 2 hour post prandial glucose values, insulin levels and HbA1c. However, all of the subjects recruited did not have abnormal values to start with. The two subjects who were enrolled were the younger kids to which the entry lab criteria do not apply. | Baseline to end of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, Glucose Intolerance, Obesity, Vyvanse