Back to resultsVyvanse and Glucose Intolerance in Children With Attention Deficit Hyperactivity Disorder (ADHD) and Obesity
Primary Purpose
Attention Deficit Hyperactivity Disorder, Glucose Intolerance, Obesity
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lis-dexamphetamine
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD, Glucose Intolerance, Obesity, Vyvanse
Eligibility 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
Sites / Locations
- Duke Child and Family Study Center
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
Open label Vyvanse
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01017263
First Posted
November 19, 2009
Last Updated
February 18, 2014
Sponsor
Duke University
Collaborators
Shire
1. Study Identification
Unique Protocol Identification Number
NCT01017263
Brief Title
Vyvanse and Glucose Intolerance in Children With Attention Deficit Hyperactivity Disorder (ADHD) and Obesity
Official Title
Vyvanse and Glucose Intolerance in Children With ADHD and Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Terminated
Why Stopped
Due very high screen fail rate, pre study feasibility not consistent with screened population.
Study Start Date
December 2009 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Shire
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder, Glucose Intolerance, Obesity
Keywords
ADHD, Glucose Intolerance, Obesity, Vyvanse
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open label Vyvanse
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lis-dexamphetamine
Other Intervention Name(s)
Vyvanse, LDX
Intervention Description
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 Measure Information:
Title
Pre and Post Study Fasting Blood Sugar and Two Hour Post Prandial.
Description
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.
Time Frame
Baseline to end of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott H Kollins, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Child and Family Study Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Vyvanse and Glucose Intolerance in Children With Attention Deficit Hyperactivity Disorder (ADHD) and Obesity
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