NCT00005380

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Sep 1993

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1993

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 1998

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2000

Completed
Last Updated

May 13, 2016

Status Verified

March 1, 2005

First QC Date

May 25, 2000

Last Update Submit

May 12, 2016

Conditions

Eligibility Criteria

AgeUp to 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
No eligibility criteria

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (11)

  • Falkner B. The role of cardiovascular reactivity as a mediator of hypertension in African Americans. Semin Nephrol. 1996 Mar;16(2):117-25.

    PMID: 8668859BACKGROUND
  • 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. doi: 10.1016/s0026-0495(97)90055-x.

    PMID: 9109843BACKGROUND
  • 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. doi: 10.1007/BF02637090.

    PMID: 8729133BACKGROUND
  • 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. doi: 10.1161/01.hyp.34.5.1086.

    PMID: 10567186BACKGROUND
  • 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. doi: 10.1016/s0895-7061(99)00041-2.

    PMID: 10480466BACKGROUND
  • 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. doi: 10.2337/diacare.22.1.71.

    PMID: 10333906BACKGROUND
  • Falkner B, Sherif K, Sumner A, Kushner H. Hyperinsulinism and sex hormones in young adult African Americans. Metabolism. 1999 Jan;48(1):107-12. doi: 10.1016/s0026-0495(99)90018-5.

    PMID: 9920153BACKGROUND
  • 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. doi: 10.1002/j.1550-8528.1998.tb00326.x.

    PMID: 9545019BACKGROUND
  • 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.

    PMID: 12148703BACKGROUND
  • 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. doi: 10.1097/00000441-200205000-00001.

    PMID: 12018664BACKGROUND
  • 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. doi: 10.1111/j.1524-6175.2002.01211.x.

    PMID: 11821633BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesDiabetes MellitusHypertensionHeart DiseasesHyperinsulinismInsulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular Diseases

Study Officials

  • Bonita Falkner

    Drexel University

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

May 25, 2000

First Posted

May 26, 2000

Study Start

September 1, 1993

Study Completion

August 1, 1998

Last Updated

May 13, 2016

Record last verified: 2005-03