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Insulin, Androgen, and Risk in African-American Women

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005380
First received: May 25, 2000
Last updated: June 23, 2005
Last verified: March 2005
  Purpose

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.


Condition
Cardiovascular Diseases
Diabetes Mellitus
Hypertension
Heart Diseases
Hyperinsulinism
Insulin Resistance

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 1993
Estimated Study Completion Date: August 1998
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.

As part of a collaborative project on minority health, Dr. Falkner is collaborating with Dr. Thomas Tulenko (R01HL51538) and Dr. Julian Marsh (R01HL51536).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00005380

Sponsors and Collaborators
Investigators
Investigator: Bonita Falkner Drexel University
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00005380     History of Changes
Other Study ID Numbers: 4284
Study First Received: May 25, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Heart Diseases
Hyperinsulinism
Hypertension
Insulin Resistance
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014