Coronary Atherosclerosis and Cardiovascular Performance in Polycystic Ovarian Syndrome

Study ID
Study00000980

Cancer Related
No

Healthy Volunteers
Yes

Study Sites

Contact
Samantha Thompson
214-648-2320
samantha.thompson@utsouthwestern.edu

Principal Investigator
Alice Chang

Summary

This case-control study will compare the coronary artery flow velocity reserve, myocardial blood flow reserve and peak oxygen uptake between 30 women with PCOS and insulin resistance and 30 controls without PCOS who also have insulin resistance. We will match the groups by self-identified ethnicity, mean age and BMI. We anticipate it will take 3 years to complete recruitment. The study consists of three procedures: cardiac imaging, a glucose tolerance test, and an exercise test. We will use MRI to measure coronary artery flow velocity reserve and myocardial blood flow reserve. We will measure insulin sensitivity with the frequently sampled intravenous glucose tolerance test. During the exercise treadmill test, we will measure peak oxygen uptake (VO2max), cardiac output, total peripheral resistance and stroke volume. The study will include 2 major visits after the screening visit: (1) first visit at UT Southwestern Medical Center for the fasting intravenous glucose tolerance test, body composition measurements and MRI study, (2) second visit at the Institute of Exercise and Environmental Medicine (IEEM) at Texas Health Presbyterian Hospital of Dallas for exercise testing.

Interventions by visit: Visit 1 Visit 2 Visit 3
Interventions Screening Visit CTRC IEEM
Informed Consent yes
History yes yes
Height and Weight yes yes
Urine pregnancy test yes yes
Blood draw 5ml 30ml
EKG yes
MRI yes
Administer Adenosine yes

FSIGT yes
Administer Insulin yes
Exercise Test yes
Body composition (waist and yes
hip circumference, body density)

Participants will be given the option of staying overnight at the CTRC between the MRI and the Frequently Sampled Intravenous Glucose Tolerance Test or having both tests done as an outpatient over the course of one day. Only the order of tests will be different. For the overnight stay, participants may have the MRI done first after 4pm at Rogers and then be admitted as an inpatient to the CTRC after the MRI. The Frequently Sampled Intravenous Glucose Tolerance Test will be conducted in the morning with the underwater weighing conducted after lunch. No additional testing will be conducted during inpatient overnight stay.

Participant Eligibility

The participant population will consist of healthy premenopausal young women, ages 30 to 50, who are overweight with a BMI of 25 to 35 kg/m2 and have insulin resistance. Insulin resistance is defined as an elevated fasting insulin concentration > 20 [MICRO-SYMBOL]U/ml (the 75th percentile for women ages 35 to 49 in the Dallas Heart Study who did not have diabetes by history or by a fasting glucose >= 126 mg/dl) associated with the characteristic dyslipidemia for women: HDL cholesterol < 50 mg/dl and/or triglycerides > 150 mg/dl. All participants must be premenopausal and must have a negative urine pregnancy at the screening and prior to imaging. Women who use preparations containing estrogens, progestins, anti-androgens or anti-diabetic medications will be required to withdraw from the medication for 3 months prior to the study and (use another form of contraception if applicable). Participants of all races will be eligible. Because of the need for participants to follow instructions closely during the imaging and the exercise test and the inability to provide a translator during these procedures, we will only be able to include women who speak English.
Women with PCOS will be eligible if they have oligomenorrhea (< 9 menses per year), clinical hirsutism (Ferriman-Gallway score > 8 or severe acne) or an elevated total testosterone greater than 2 standard deviations above the assay mean. For each PCOS participant, one control women without PCOS will be selected with the above criteria but matched by self-identified ethnicity. The groups will be matched for mean age and BMI. Women without PCOS will need to have regular menstrual cycles of [Approx.]28 to 35 days and cannot meet any criteria for PCOS above. All participants must have the ability to give informed consent. The risks and benefits will be explained in detail to participants before each signs an institutionally approved consent form. Pregnant women, neonates, children, or institutionalized individuals will not be included.