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

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Duke University

Status and phase

Terminated
Phase 4

Conditions

Attention Deficit Hyperactivity Disorder
Obesity
Glucose Intolerance

Treatments

Drug: Lis-dexamphetamine

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01017263
Pro00019063

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

All

Ages

8 to 17 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

14 participants in 1 patient group

Open label Vyvanse
Active Comparator group
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.
Treatment:
Drug: Lis-dexamphetamine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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