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

Phase 4

Terminated

• Conditions: Attention Deficit Hyperactivity Disorder; Glucose Intolerance; Obesity
• Interventions: Drug: Lis-dexamphetamine

• Registration Number: NCT01017263
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2009-11-19
• Study First Submitted QC: 2009-11-19
• Study First Posted: 2009-11-20
• Study Start: 2009-12
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2013-09
• Results First Submitted: 2013-09-13
• Results First Submitted QC: 2014-02-18
• Last Update Submitted: 2014-02-18
• Results First Posted: 2014-02-20
• Last Update Posted: 2014-02-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open label Vyvanse	Lis-dexamphetamine	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.

Primary Outcome Measures

Name	Time	Method
Pre and Post Study Fasting Blood Sugar and Two Hour Post Prandial.	Baseline to end of study	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.

Trial Locations

Locations (1)

Duke Child and Family Study Center; 🇺🇸 Durham, North Carolina, United States