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

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Metabolic Syndrome

In brief

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.

Key facts

Study ID

NCT00438321

Run by

Massachusetts General Hospital

People needed

66

Starts

2006-09-01

Expected to finish

2010-02-26

Last updated by the study team

2017-04-18

Who can join

Age: 50 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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)

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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