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Atherosclerosis, Cardiovascular Diseases, Heart Diseases, Carotid Artery Diseases, Coronary Disease, Polycystic Ovary Syndrome

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Trial Information


The risk of coronary heart disease (CHD) is lower in women than men. This has been
attributed to differences in sex hormones, insulin sensitivity, and environmental factors.
Women with Polycystic Ovary syndrome have characteristics, including anovulation,
hyperandrogenism and insulin resistance, which suggests a male risk factor profile. The
study tests the hypothesis that women with PCOS are at greater risk of coronary heart
disease than non-PCOS women. When the study was initiated in 1991, there were few data
available on long-term followup of women with PCOS.


Beginning in 1991, the investigators tested the hypothesis that women with PCOS, who
comprise 5 percent of the female population, are at greater risk of coronary heart disease
than non-PCOS women. They traced and followed-up, via telephone interviews, 244 women with
PCOS and 244 age-matched neighborhood controls. They then conducted a cross-sectional study
to assess reproductive, hormonal and other coronary heart disease risk factors in the women
with PCOS compared with the controls. Evaluation consisted of an office visit to determine
total cholesterol, triglycerides, HDL cholesterol, fasting and two hour glucose and insulin,
blood pressure, lifetime cigarette smoking, alcohol intake, reproductive history, lifetime
medication usage, family history of PCOS, and serum hormone concentrations. At this
evaluation, a physician diagnosis of PCOS from history, physical exam, and hormone studies
was made. In addition, information on the number of pregnancies, number of live births,
menstrual history, and history of surgical or natural menopause was obtained. Women with
evidence of thyroid, adrenal or pituitary disease were excluded.

The grant was renewed in 1996 to determine whether women with PCOS have evidence of an
increased prevalence rate of subclinical atherosclerosis. Within the PCOS population the
investigators performed five studies to further determine risk factors for subclinical
atherosclerosis. First, they evaluated the relationship between PCOS and subclinical
atherosclerosis as measured by carotid ultrasound. In this study, they determined whether
women, thirty years of age or older with PCOS, had a higher prevalence of subclinical
atherosclerosis than age-matched control women. Second, they evaluated the relationship
between PCOS and subclinical vascular disease as measured by brachial artery flow mediated
vasodilation. They determined whether PCOS cases had lower brachial artery flow mediated
vasodilation than controls, and whether the distribution of flow mediated vasodilation was
related to the extent of carotid artery wall thickness and plaque. Third, they evaluated
whether subclinical atherosclerosis and vascular disease were related to the following
cardiovascular risk factors within PCOS cases and controls: HDL cholesterol, LDL
cholesterol, triglycerides, insulin, systolic and diastolic blood pressure and testosterone,
waist-to-hip ratio and body mass index (BMI). Fourth, they assessed differences in body
composition between PCOS cases and control women, including intra-abdominal fat as measured
by computed tomography (CT) of the abdomen and sagittal diameter, and percent body fat as
measured by dual energy x-ray absorptiometry (DEXA). They evaluated the relationship between
subclinical atherosclerosis and body composition separately for cases and for controls.
Previous studies had clearly shown that PCOS women were different from obese non-PCOS women.
Moreover, insulin, testosterone and coronary heart disease risk factors were also correlated
with these measures using paired t-tests. Multiple regression was used to test whether PCOS
cases compared to controls had an increase in intra-abdominal fat which was independent of
important confounders. Fifth, they compared plasma levels of selected coagulation factors
including fibrinogen and factor VII to fibrinolytic factors for PCOS cases and controls.

The study was renewed in September 2000 through August 2004 to continue follow-up.

Inclusion Criteria

No eligibility criteria

Type of Study:


Study Design:


Principal Investigator

Evelyn Talbott

Investigator Affiliation:

University of Pittsburgh


United States: Federal Government

Study ID:




Start Date:

September 2000

Completion Date:

August 2006

Related Keywords:

  • Atherosclerosis
  • Cardiovascular Diseases
  • Heart Diseases
  • Carotid Artery Diseases
  • Coronary Disease
  • Polycystic Ovary Syndrome
  • Atherosclerosis
  • Cardiovascular Diseases
  • Carotid Artery Diseases
  • Coronary Artery Disease
  • Myocardial Ischemia
  • Coronary Disease
  • Heart Diseases
  • Polycystic Ovary Syndrome