Blood Vessel Function in Adolescents and Women With Polycystic Ovary Syndrome
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|ClinicalTrials.gov Identifier: NCT01615562|
Recruitment Status : Terminated (Difficulty in enrolling suitable subjects)
First Posted : June 8, 2012
Last Update Posted : December 14, 2015
|Condition or disease|
|Polycystic Ovary Syndrome (PCOS)|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||18 participants|
|Observational Model:||Case Control|
|Official Title:||Endothelial Dysfunction in Adolescents and Women With Polycystic Ovary Syndrome (PCOS)|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||July 2015|
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).
- Peripheral vascular imaging via ultrasonography during brachial artery flow-mediated vasodilation (FMD) [ Time Frame: ~ 30 minutes ]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 ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01615562
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Edmond Wickham, MD||Virginia Commonwealth University|