Study Title

Mechanisms of Hypertension in Women with Polycystic Ovary Syndrome

Why is this study being done?

• High blood pressure and cardiovascular disease remains the greatest killer in women.
• Women with PCOS women are at risk for both high blood pressure and cardiovascular disease because women with PCOS may be obese/overweight, have insulin resistance and/or elevations in androgens
• Our study is designed to determine the major causes for the high blood pressure in women with PCOS
• Both blood pressure regulation on cardiovascular disease risk are important factors that should be incorporated into medical treatment plans for women with PCOS at all ages

Screening includes having an oral glucose tolerance test to measure blood glucose and insulin levels. If you have impaired glucose tolerance and you are overweight or moderately obese, you are eligible to participate in the rest of the study. The study includes taking hormone medications and tests that measure blood pressure regulation.

Goals

• Our goal is to understand the mechanisms of impaired blood regulation in women with PCOS
• Aims of this study focus on testosterone exposure and insulin resistance (IR) as the potential causes of mild hypertension in women with PCOS that are overweight or obese
• The study also aims to examine testosterone and IR effects in overweight and obese women that do not have PCOS
• By understanding the role of hormones and IR in blood pressure regulation, our study hopes to improve treatment plans for women with PCOS

Eligibility Criteria

You can participate if you are a woman who meets the following criteria:

• Age 18 to 40 years
• Have Polycystic Ovary Syndrome OR you can participate as a Control subject if you meet the other criteria
• Are Overweight or Obese based on your body mass index (BMI of 25–30 kg/m2): To calculate your BMI: https://www.nhlbi.nih.gov/health/educational/lose_wt/BMI/bmicalc.htm
• Do not smoke
• Do not take medications for high blood pressure, diabetes, or insulin resistance—other medications are reviewed by our study clinician before enrollment
• Are comfortable communicating in English

Location

This study requires at least 4 in-person visits to our research laboratory in New Haven, Connecticut:

• The John B. Pierce Laboratory, 290 Congress, New Haven, CT 06519
• The Pierce Laboratory is right across the street from Yale University’s School of Medicine

Principal Investigators and Sub-Investigators at The John B. Pierce Laboratory and Yale School of Medicine

• Principal Investigator: Nina Stachenfeld, PhD
• Sub-Investigator: Christopher L Moore, MD
• Sub-Investigator: Lubna Pal, MBBS, FACOG, MS

Where to Go For Further Information

• Visit: https://medicine.yale.edu/ycci/clinicaltrials/trial/mechanisms-of-hypertension-in-women-with-polycystic-ovary-syndrome/
• Email: researchsubjects@jbpierce.org
• Call: 203-256-9901 x256