Vascular Effects of Attention Deficit Hyperactivity Disorder (ADHD) Medications in Youth
4.4 million children and adolescents in the United States have been diagnosed with attention deficit hyperactivity disorder (ADHD) and more than half are treated with medication. Most ADHD medications are stimulants, which activate the sympathetic nervous system (SNS). SNS activation is closely associated with vascular functional and mechanical abnormalities. Therefore, ADHD medications, via instigating SNS activation and altering the hemodynamic profile, may have untoward effects on the vasculature and increase risk of developing cardiovascular disease in children and adolescents who use them.
Our overall objective in this study is to determine whether ADHD medication use is associated SNS activation, endothelial dysfunction, and arterial stiffness in children and adolescents. We will address this objective by conducting a case-control study and obtain non-invasive measures of SNS activation, endothelial function, and arterial stiffness in children and adolescents (8-17 years old) with (using stimulant medication) and without ADHD.
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||Vascular Consequences of ADHD Medication Use in Children and Adolescents|
- Arterial stiffness [ Time Frame: Baseline ] [ Designated as safety issue: No ]Carotid-radial pulse wave velocity and aortic augmentation index.
- SNS activation [ Time Frame: Baseline ] [ Designated as safety issue: No ]Heart rate variability.
- Endothelial Function [ Time Frame: Baseline ] [ Designated as safety issue: No ]Digital reactive hyperemia and brachial artery flow-mediated dilation
|Study Start Date:||January 2010|
|Study Completion Date:||July 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
SPECIFIC AIMS AND HYPOTHESES
Our overall objective in this study is to determine whether ADHD medication use is associated SNS activation, endothelial dysfunction, and arterial stiffness in children and adolescents.
Our hypothesis is:
Children and adolescents taking ADHD medications will have higher SNS activation, lower digital reactive hyperemia, and higher pulse wave velocity and aortic augmentation index compared to sibling controls without ADHD.
Study Design We will obtain non-invasive measures of SNS activation (heart rate variability), endothelial function (digital reactive hyperemia and brachial artery flow-mediated dilation), and arterial stiffness (carotid-radial pulse wave velocity; aortic augmentation index) in youth taking ADHD stimulant medication and in their healthy siblings without ADHD.
Study visits will be conducted at the Clinical and Translational Science Institute (CTSI) at the University of Minnesota. All vascular testing will occur in the Vascular Biology Laboratory within the CTSI.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01107301
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Aaron S. Kelly, Ph.D.||University of Minnesota - Clinical and Translational Science Institute|