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

Obesity Clinical Trial

Official title:

Vyvanse and Glucose Intolerance in Children With ADHD and Obesity

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01017263
• Other study ID #: Pro00019063
• Status: Terminated
• Phase: Phase 4
• First received: November 19, 2009
• Last updated: February 18, 2014
• Start date: December 2009
• Est. completion date: August 2012

Study information

• Verified date: September 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 17 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Glucose Intolerance
• Hyperkinesis
• Obesity

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Duke Child and Family Study Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Shire

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes

External Links

•   Duke ADHD Program website