Insulin, Androgen, and Risk in African-American Women
|First Received Date ICMJE||May 25, 2000|
|Last Updated Date||June 23, 2005|
|Start Date ICMJE||September 1993|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00005380 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Insulin, Androgen, and Risk in African-American Women|
|Official Title ICMJE||Not Provided|
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.
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.
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.
As part of a collaborative project on minority health, Dr. Falkner is collaborating with Dr. Thomas Tulenko (R01HL51538) and Dr. Julian Marsh (R01HL51536).
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Enrollment ICMJE||Not Provided|
|Completion Date||August 1998|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
No eligibility criteria
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Not Provided|
|NCT Number ICMJE||NCT00005380|
|Other Study ID Numbers ICMJE||4284|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Heart, Lung, and Blood Institute (NHLBI)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Heart, Lung, and Blood Institute (NHLBI)|
|Verification Date||March 2005|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP