Insulin Resistance and Testosterone in Women

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Pennsylvania
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institute on Aging (NIA); TAP Pharmaceutical Products Inc.; The John A. Hartford Foundation; University of Pennsylvania Diabetes and Endocrinology Research Center (DERC)
• Treatments: Leuprolide; Metformin; Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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