Blood Vessel Function in Adolescents and Women With Polycystic Ovary Syndrome

NCT01615562 | Terminated DMC

• 2 other identifiers: U54HD034449- Wickham PilotU54HD034449
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Polycystic Ovary Syndrome (PCOS)

Keywords

Polycystic Ovary Syndrome; PCOS; Infertility

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• FMD with non-endothelial dependent (NED) vessel dilation

  ~30 minutes

Study Arms (2)

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).

Eligibility Criteria

• Age: 14 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Links

• VCU PCOS Research Site

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and plasma for analysis of hormones

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Infertility

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Edmond Wickham, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2012
• First Posted: June 8, 2012
• Study Start: December 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: July 1, 2015
• Last Updated: December 14, 2015

Record last verified: 2015-12

Locations

US (1)