Polycystic Ovary Syndrome (PCOS) Clinical Trial
Official title:
Endothelial Dysfunction in Adolescents and Women With Polycystic Ovary Syndrome (PCOS)
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.
Status | Terminated |
Enrollment | 18 |
Est. completion date | July 2015 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 14 Years to 40 Years |
Eligibility |
Inclusion Criteria: - PCOS as defined by NIH/NICHD criteria: 1) oligo- or amenorrhea (=8 menstrual periods annually, persisting 2 years post menarche); 2) biochemical hyperandrogenism(HA), i.e.,elevated total or free testosterone concentration and/or clinical evidence of HA (defined as the presence of hirsutism); and 3) exclusion of secondary causes of ovulatory dysfunction and HA (including hyperprolactinemia, thyroid dysfunction, non-classical congenital adrenal hyperplasia (NCAH) due to 21-hydroxylase deficiency, Cushing syndrome, androgen secreting neoplasms, and androgenic/anabolic drug use). - Inclusion criteria for adolescent and adult control subjects will include 1) normal menstrual periods (defined as regular cycles between 22-36 days in length); 2) normal serum androgens (total/free testosterone and dehydroepiandrosterone-sulfate [DHEA-S]); and 3) absence of clinical evidence of hyperandrogenism. Additionally, adolescent controls must be 2 years post menarche. Exclusion Criteria: - Diabetes mellitus - Underlying endocrine, neurologic, and/or genetic syndromes leading to obesity - Congenital heart disease or abnormal resting ECG - Renal or hepatic disease - History of rheumatologic disorders or malignancy - Use of medications or dietary supplements known to affect insulin sensitivity (i.e. metformin, corticosteroids, and oral contraceptive pills), blood pressure, or cholesterol within 3 months of study participation - Investigation drug use within 3 months of study participation - Pregnancy - Current tobacco use |
Observational Model: Case Control, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
United States | Virginia Commonwealth University | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Commonwealth University | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Peripheral vascular imaging via ultrasonography during brachial artery flow-mediated vasodilation (FMD) | 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 | ~ 30 minutes | No |
Secondary | FMD with non-endothelial dependent (NED) vessel dilation | 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. | ~30 minutes | No |
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