Hypertension Clinical Trial
To distinguish whether the observed gender differences in plasma insulin and insulin resistance reflect biologic differences, or whether the gender differences in insulinemia are determined by greater adiposity in women. Also, to determine if the hyperinsulinemia per se contributes to excess risk for cardiovascular disease in African American women. Finally, since higher androgenicity is linked with cardiovascular risk in women, to determine if the risk factors associated with hyperinsulinemia are modulated by sex hormones.
BACKGROUND:
Hyperinsulinemia and insulin resistance are strongly linked with essential hypertension (EH)
and non-insulin dependent diabetes mellitus (NIDDM), both of which afflict African American
women with greater incidence, morbidity, and mortality compared to Caucasians. The insulin
resistance syndrome is often characterized by upper body obesity. In women, this body
morphology is related to higher levels of androgens. In young adult African Americans the
investigators have detected significant gender differences in both hyperinsulinemia and
insulin resistance, with African American women exhibiting higher plasma insulin and greater
insulin resistance compared to men
Results of these studies should help to determine if insulin and androgens define risk for
cardiovascular disease in African American women. These data can lead to new insights to the
excess prevalence of EH and NIDDM in African American women, and to the development of
strategies for prevention.
The study was part of an NHLBI initiative on Collaborative Projects (R01s) on Minority
Health. The 1993 Report of the Committee on Appropriations, House of Representatives,
encouraged the NHLBI to establish minority centers to facilitate the diagnosis and treatment
of cardiovascular disease. The concept for the initiative was developed by Institute staff
and approved by the National Heart, Lung, and Blood Advisory Council in September, 1992. The
Institute-wide Request for Applications was released in October, 1992.
DESIGN NARRATIVE:
The study was designed to test the overall hypothesis that cosegregation of hyperinsulinemia
and androgenicity correlated with greater cardiovascular risk in African American women.
Women who have hyperinsulinemia and higher androgen levels have high blood pressure,
impaired glucose tolerance, and altered serum lipids, as compared to women who do not have
both phenotypes. The study was conducted on a population of young adult African American men
and women that had been studied longitudinally. Mothers of the young women were also
studied. The investigators: obtained anthropometric and blood pressure measures; quantitated
glucose tolerance by glucose tolerance test, and insulin sensitivity by insulin clamp;
measured serum lipids; and assessed androgen levels using assays of plasma sex-hormone
binding globulin and free testosterone.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.
As part of a collaborative project on minority health, Dr. Falkner is collaborating with Dr.
Thomas Tulenko (R01HL51538) and Dr. Julian Marsh (R01HL51536).
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