Blood Vessel Function in Adolescents and Women With Polycystic Ovary Syndrome
The purpose of this study is to determine if changes in blood vessel health lead to the menstrual irregularities that women with PCOS experience. This research study will help determine if women with PCOS have early changes in their blood vessels called "endothelial dysfunction," and if the number of progenitor cells (cells that in a healthy person repair blood vessel damage) are related to these blood vessel changes. To do so, we will compare ultrasound (soundwave) pictures of a large blood vessel in the arm and the results of blood tests between women with PCOS and other healthy women with normal menstrual periods.
Polycystic Ovary Syndrome (PCOS)
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||Endothelial Dysfunction in Adolescents and Women With Polycystic Ovary Syndrome (PCOS)|
- Peripheral vascular imaging via ultrasonography during brachial artery flow-mediated vasodilation (FMD) [ Time Frame: ~ 30 minutes ] [ Designated as safety issue: No ]A blood pressure cuff is placed on right forearm. A 7-12MHz linear array ultrasound transducer is placed on upper arm. 2-D and Doppler images are acquired. Forearm cuff is inflated to ~ 50 mmHg above resting systolic blood pressure (max 300 mmHg) for 4.5 minutes, then deflated. Blood flow velocity via Doppler is recorded for 15 seconds; 2D-images of the brachial artery are collected for 3 minutes. Brachial artery diameter is measured at end diastole (R-wave on ECG).FMD is determined: %FMD=(LDp-LDb)/LDbx100, where LDp=luminal diameter after inflation and LDb=luminal diameter at baseline
- FMD with non-endothelial dependent (NED) vessel dilation [ Time Frame: ~30 minutes ] [ Designated as safety issue: No ]NED testing will be performed following a rest period of at least 15 minutes from completion of the FMD testing. For NED testing, a second baseline and 2D image and Doppler signal will be performed as previously outlined. Following repeat baseline imaging, 400 μg of nitroglycerin will be administered sublingually, and images will be recorded for at least 3 minutes following the administration of nitroglycerin. Only adult subjects will undergo NED.
Biospecimen Retention: Samples Without DNA
serum and plasma for analysis of hormones
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||September 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Post-menarchal females ages 14-17 with and without PCOS (15 each group for a total of 30 subjects).
Women ages 18-40 with and without PCOS (15 each group for a total of 30 subjects).
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01615562
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Edmond Wickham, MD||Virginia Commonwealth University|