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

Phase 4TerminatedNCT01017263

Duke University14 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Attention Deficit Hyperactivity Disorder Glucose Intolerance Obesity

Interventions

Lis-dexamphetamineDRUG

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.

Eligibility

Sex: ALLMin age: 8 YearsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Duke Child and Family Study Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline to end of study

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.