drugset / Trial / NCT00123110
Insulin Resistance and Testosterone in Women
Phase 2
Completed
35 enrolled
University of Pennsylvania
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collabNational Institute on Aging (NIA) · collabTAP Pharmaceutical Products Inc. · collabThe John A. Hartford Foundation · collabUniversity of Pennsylvania Diabetes and Endocrinology Research Center (DERC) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this research study is to determine if a relationship between insulin resistance (IR) and testosterone (T) exists in women who have already gone through menopause.
Timeline
- Start
- 2005-07
- Primary completion
- 2011-12
- Completion
- 2011-12
Publications
- Background Ford ES, Giles WH, Dietz WH. Prevalence of the metabolic syndrome among US adults: findings from the third National Health and Nutrition Examination Survey. JAMA. 2002 Jan 16;287(3):356-9. doi: 10.1001/jama.287.3.356.
- Background Golden SH, Ding J, Szklo M, Schmidt MI, Duncan BB, Dobs A. Glucose and insulin components of the metabolic syndrome are associated with hyperandrogenism in postmenopausal women: the atherosclerosis risk in communities study. Am J Epidemiol. 2004 Sep 15;160(6):540-8. doi: 10.1093/aje/kwh250.
- Background Larsson H, Ahren B. Androgen activity as a risk factor for impaired glucose tolerance in postmenopausal women. Diabetes Care. 1996 Dec;19(12):1399-403. doi: 10.2337/diacare.19.12.1399.
- Background Oh JY, Barrett-Connor E, Wedick NM, Wingard DL; Rancho Bernardo Study. Endogenous sex hormones and the development of type 2 diabetes in older men and women: the Rancho Bernardo study. Diabetes Care. 2002 Jan;25(1):55-60. doi: 10.2337/diacare.25.1.55.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Leuprolide | Other / unclassified | 3.75 mg | Other |
| Subject | Metformin | Small molecule | 1000 mg | Oral |
Indications
No indication recorded.