Attention Deficit Hyperactivity Disorder, Glucose Intolerance, Obesity
Conditions
Keywords
ADHD, Glucose Intolerance, Obesity, Vyvanse
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.
Interventions
DRUGLis-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.
Sponsors
Shire
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pre and Post Study Fasting Blood Sugar and Two Hour Post Prandial. | 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. |
Countries
United States
Participant flow
Recruitment details
Potential participants are pre-screened at the Duke Obesity Clinic. Eligible participants then come to the Duke ADHD Clinic for their first study visit.
Pre-assignment details
At the screening visit, psychiatric evaluation and fasting labs were obtained to determine eligibility. Of the 14 subjects only 2 qualified and received study drug. Reasons for screen fails: 8-did not meet lab parameters for glucose intolerance, 1-elevated BP, 1- elevated TSH, 1- doing well with current ADHD treatment, 1- diagnosed with depression.
Participants by arm
| Arm | Count |
|---|---|
| Open Label Vyvanse All subjects receive Vyvanse. | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | not eligible | 12 |
Baseline characteristics
| Characteristic | Open Label Vyvanse |
|---|---|
| Age, Categorical <=18 years | 14 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 10.92 years STANDARD_DEVIATION 2.73 |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
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.
Time frame: Baseline to end of study
Population: Study terminated early - no analysis performed on the single subject with data.