Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00058669 |
| Other study ID # |
1210 |
| Secondary ID |
R01HL067052 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
April 10, 2003 |
| Last updated |
January 4, 2016 |
| Start date |
March 2003 |
| Est. completion date |
February 2008 |
Study information
| Verified date |
January 2016 |
| Source |
University of Pittsburgh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Observational
|
Clinical Trial Summary
To examine potential differences in the prevalence and pattern of risk factors for coronary
heart disease in a sample of 500 self-identified lesbians and 500 heterosexual women,
matched for age, socioeconomic status, and ethnicity.
Description:
BACKGROUND:
Coronary heart disease (CHD) is the leading cause of mortality among women living in the
United States, regardless of race and ethnicity and is likely the leading cause of mortality
among lesbians. However, in various reports since 1994, the National Institute of Mental
Health, the Centers for Disease Control and Prevention, the American Medical Association,
the American Public Health Association, and the Institute of Medicine (IOM) have pointed out
that health care and health research affecting lesbian women are inadequate. As women,
lesbians share many of the same health concerns of all women. However, as emphasized in the
IOM Report on Lesbian Health "factors assumed to place women at risk for or to protect them
against health disorders may not be present at the same levels or operate in the same way
for lesbians". The IOM report also recognizes that "women who self-identify as lesbian may
also experience stressors not commonly faced by heterosexual women" and that "it is
important to understand the factors that are unique to lesbians and their impact on
lesbians' health". Data which do exist from household surveys and studies utilizing
convenience samples indicate that women who identify as lesbian may differ from heterosexual
women in several important factors which contribute to the development of CHD. However, to
date there has not been a comprehensive examination of CHD risk in a large sample of women
who identify as lesbian or an examination of how their pattern of risk factors or overall
risk for CHD may differ from a sample of demographically similar heterosexual women.
DESIGN NARRATIVE:
The study is a case-control, cross-sectional survey that includes both behavior (alcohol,
smoking, substance use, physical activity) and physiological (lipids, blood pressure,
adiposity) measures. Self-identified lesbian women will be age, education, and racially
matched to heterosexual women. The study will test the hypotheses that the prevalence and
pattern of coronary heart disease (CHD) risk factors are different between lesbians and
heterosexual women. The study will also determine the absolute and relative risk estimates
for CHD based on the Framingham multiple-risk-factor assessment equations, and test the
hypothesis that lesbians are at increased risk of CHD compared to heterosexual women.
