Effect of Increasing Testosterone on Insulin Sensitivity in Men With the Metabolic Syndrome

• Status: Terminated
• Trial end date: 2010-02-26
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of the study is to examine the effect of testosterone treatment on insulin in men with the metabolic syndrome with testosterone levels at or below the lower end of the normal range.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: American Diabetes Association; National Institutes of Health (NIH)
• Treatments: Anastrozole; Goserelin; Insulin; Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

Stable weight for previous three months (no weight change greater than or equal to +/-10 lbs)

Exclusion Criteria:

• No new diagnosis of type 2 diabetes or on oral hypoglycemic agents

• No history of testicular disorders

• No history of bleeding disorders (i.e. Pulmonary Embolism, Deep Vein Thrombosis, stroke, hypercoagulable syndrome)

• No history of prostate cancer

• No previous diagnosis of osteoporosis

• No history of sleep apnea (subjects will also be excluded if at their baseline assessment they admit to heavy snoring, restless sleep, and/or excessive daytime somnolence)

• No symptoms of urinary outflow obstruction or medications for prostate disease

• No illicit drug use or heavy alcohol use (>4 drinks/day)