- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01017263
Vyvanse and Glucose Intolerance in Children With Attention Deficit Hyperactivity Disorder (ADHD) and Obesity
February 18, 2014 updated by: Duke University
Vyvanse and Glucose Intolerance in Children With ADHD and Obesity
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.
Study Overview
Status
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27705
- Duke Child and Family Study Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Open label Vyvanse
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.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pre and Post Study Fasting Blood Sugar and Two Hour Post Prandial.
Time Frame: 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.
|
Baseline to end of study
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Scott H Kollins, PhD, Duke University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
November 19, 2009
First Submitted That Met QC Criteria
November 19, 2009
First Posted (Estimate)
November 20, 2009
Study Record Updates
Last Update Posted (Estimate)
February 20, 2014
Last Update Submitted That Met QC Criteria
February 18, 2014
Last Verified
September 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Glucose Metabolism Disorders
- Metabolic Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Overnutrition
- Nutrition Disorders
- Overweight
- Body Weight
- Dyskinesias
- Hyperglycemia
- Attention Deficit and Disruptive Behavior Disorders
- Neurodevelopmental Disorders
- Obesity
- Glucose Intolerance
- Attention Deficit Disorder with Hyperactivity
- Hyperkinesis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Lisdexamfetamine Dimesylate
- Dextroamphetamine
Other Study ID Numbers
- Pro00019063
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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