Blood Vessel Function in Adolescents and Women With Polycystic Ovary Syndrome

This study is currently recruiting participants.
Verified December 2013 by Virginia Commonwealth University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01615562
First received: June 6, 2012
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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.


Condition
Polycystic Ovary Syndrome (PCOS)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Endothelial Dysfunction in Adolescents and Women With PCOS

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 60
Study Start Date: December 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
PCOS adolescents
Post-menarchal females ages 14-17 with and without PCOS (15 each group for a total of 30 subjects).
PCOS women
Women ages 18-40 with and without PCOS (15 each group for a total of 30 subjects).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   14 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Specifically the study will enroll: 15 treatment-naïve adolescents with PCOS; 15 age- and BMI Z-score matched adolescent controls without PCOS; 15 adult treatment-naïve women with PCOS; and 15 age- and BMI-matched adult women without PCOS. Subject race/ethnicity is not a specific inclusion/exclusion criterion for this study.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01615562

Contacts
Contact: Maria Shulleeta, MS 804-828-9697 mshulleeta@vcu.edu

Locations
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Maria Shulleeta, MS    804-828-9697    mshulleeta@vcu.edu   
Contact: Edmond Wickham, MD    804 827-0453    ewickham@mcvh-vcu.edu   
Principal Investigator: Edmond Wickham, MD, MPH         
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Edmond Wickham, MD Virginia Commonwealth University
  More Information

Additional Information:
No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01615562     History of Changes
Other Study ID Numbers: U54HD034449- Wickham Pilot, U54HD034449
Study First Received: June 6, 2012
Last Updated: December 19, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
Polycystic Ovary Syndrome
PCOS
Infertility

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 15, 2014