Insulin, Androgen, and Risk in African-American Women

Tracking Information
First Submitted Date	May 25, 2000
First Posted Date	May 26, 2000
Last Update Posted Date	May 13, 2016
Study Start Date	September 1993
Primary Completion Date	Not Provided
Current Primary Outcome Measures	Not Provided
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT00005380 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Insulin, Androgen, and Risk in African-American Women
Official Title	Not Provided
Brief Summary	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.
Detailed Description	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).
Study Type	Observational
Study Design	Not Provided
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Not Provided
Study Population	Not Provided
Condition	Cardiovascular Diseases; Diabetes Mellitus; Hypertension; Heart Diseases; Hyperinsulinism; Insulin Resistance
Intervention	Not Provided
Study Groups/Cohorts	Not Provided
Publications *	Falkner B. The role of cardiovascular reactivity as a mediator of hypertension in African Americans. Semin Nephrol. 1996 Mar;16(2):117-25. Review.; Sumner AE, Kushner H, Tulenko TN, Falkner B, Marsh JB. The relationship in African-Americans of sex differences in insulin-mediated suppression of nonesterified fatty acids to sex differences in fasting triglyceride levels. Metabolism. 1997 Apr;46(4):400-5.; Sumner AE, Kushner H, Lakota CA, Falkner B, Marsh JB. Gender differences in insulin-induced free fatty acid suppression: studies in an African American population. Lipids. 1996 Mar;31 Suppl:S275-8.; Falkner B, Sherif K, Sumner AE, Kushner H. Blood pressure increase with impaired glucose tolerance in young adult american blacks. Hypertension. 1999 Nov;34(5):1086-90.; Humphries S, Kushner H, Falkner B. Low dietary magnesium is associated with insulin resistance in a sample of young, nondiabetic Black Americans. Am J Hypertens. 1999 Aug;12(8 Pt 1):747-56.; Sumner AE, Kushner H, Sherif KD, Tulenko TN, Falkner B, Marsh JB. Sex differences in African-Americans regarding sensitivity to insulin's glucoregulatory and antilipolytic actions. Diabetes Care. 1999 Jan;22(1):71-7.; Falkner B, Sherif K, Sumner A, Kushner H. Hyperinsulinism and sex hormones in young adult African Americans. Metabolism. 1999 Jan;48(1):107-12.; Sumner AE, Falkner B, Kushner H, Considine RV. Relationship of leptin concentration to gender, menopause, age, diabetes, and fat mass in African Americans. Obes Res. 1998 Mar;6(2):128-33.; Murtaugh KH, Borde-Perry WC, Campbell KL, Gidding SS, Falkner B. Obesity, smoking, and multiple cardiovascular risk factors in young adult African Americans. Ethn Dis. 2002 Summer;12(3):331-5.; Campbell KL, Borde-Perry WC, Murtaugh KH, Gidding SS, Falkner B. Glucose tolerance and cardiovascular risk in young adult African Americans. Am J Med Sci. 2002 May;323(5):231-7.; Borde-Perry WC, Campbell K, Murtaugh KH, Gidding S, Falkner B. The association between hypertension and other cardiovascular risk factors in young adult African Americans. J Clin Hypertens (Greenwich). 2002 Jan-Feb;4(1):17-22.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Enrollment	Not Provided
Original Enrollment	Not Provided
Actual Study Completion Date	August 1998
Primary Completion Date	Not Provided
Eligibility Criteria	No eligibility criteria
Sex/Gender	Sexes Eligible for Study: All
Ages	up to 100 Years (Child, Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Not Provided
Removed Location Countries
Administrative Information
NCT Number	NCT00005380
Other Study ID Numbers	4284; R01HL051547 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor	National Heart, Lung, and Blood Institute (NHLBI)
Collaborators	Not Provided
Investigators	Investigator: Bonita Falkner Drexel University
PRS Account	National Heart, Lung, and Blood Institute (NHLBI)
Verification Date	March 2005