Status:
COMPLETED
Insulin Resistance and Testosterone in Women
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Institute on Aging (NIA)
The John A. Hartford Foundation
Conditions:
Insulin Resistance
Postmenopause
Eligibility:
FEMALE
50-79 years
Phase:
PHASE2
Brief 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.
Detailed Description
This study tests the central hypothesis that insulin resistance (IR) increases androgen (male sex hormone) production in postmenopausal women. Participation will include five visits, each lasting on a...
Eligibility Criteria
Inclusion
- Postmenopausal women aged 50-79 years with absence of menses for 12 months; for women 50-54 years, Follicle stimulating hormone\>30 U/mL to confirm postmenopausal status
- At least one intact ovary
- Free testosterone and fasting insulin levels within required study parameters
- Willing to comply with all study-related procedures
- Capable of giving informed consent
Exclusion
- History of cancer requiring treatment within the past 5 years (exceptions may be made by investigator)
- Hospitalization for treatment of vascular disease in the past 6 months
- Uncontrolled hypertension
- Hospitalization for chronic obstructive pulmonary disease or asthma in the past 3 months
- Use of continuous oxygen at home
- Surgery in the last 30 days
- Positive for HIV
- Abnormal blood tests (hemoglobin, fasting triglycerides, fasting glucose, creatinine, liver function)
- History of diabetes mellitus or use of any anti-hyperglycemic medication in the past 3 months
- Disease associated with disordered glucose metabolism (Cushing's disease, acromegaly, pheochromocytoma not surgically cured, chronic pancreatitis)
- History of chronic renal insufficiency
- Intravenous (IV) contrast studies with iodinated materials planned for the 12 week intervention period that cannot be postponed according to the participant's primary care provider
- Acute or chronic metabolic acidosis
- History of liver disease
- Congestive heart failure
- History of androgen-secreting tumors
- Hormone replacement therapy or antiandrogen use in past 6 months
- Use of dehydroepiandosterone (DHEA) or other androgen-containing products in past 6 months
- Corticosteroid use, other than topical, ophthalmic, intraarticular, and inhaled preparations, in past 3 months
- Undiagnosed current vaginal bleeding
- Excessive alcohol intake, either acute or chronic; current illicit substance abuse
- Participation in an investigational drug study within 6 weeks prior to screening visit
- Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the patient's safety or successful participation in the study
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00123110
Start Date
July 1 2005
End Date
December 1 2011
Last Update
May 23 2019
Active Locations (1)
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1
University of Pennsylvania Clinical and Translational Research Center
Philadelphia, Pennsylvania, United States, 19104