Effect of Varying Testosterone Levels on Insulin Sensitivity in Men With Idiopathic Hypogonadotropic Hypogonadism (IHH)

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Hypogonadotropic Hypogonadism, Kallmann Syndrome

In brief

The investigators are doing this research study to look at the relationship between testosterone (the main sex hormone in men) and insulin (the hormone that controls blood sugar levels) in men with Idiopathic Hypogonadotropic Hypogonadism (IHH). The investigators hypothesize that normalizing testosterone levels in men with IHH enhances insulin sensitivity, reduces visceral fat, increases lean body mass, and improves the lipid profile.

Key facts

Study ID

NCT03118479

Run by

Massachusetts General Hospital

People needed

7

Starts

2010-05-01

Expected to finish

2010-09-01

Last updated by the study team

2017-04-18

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of idiopathic hypogonadotropic hypogonadism or Kallmann Syndrome
• mean testosterone level less than 300 ng/dl
• stable weight for the previous 3 months (no weight change greater than or equal to 10 lbs)
• normal serum TSH
• normal serum prolactin levels

You may not qualify if…

• Type 2 diabetes mellitus
• history of diabetes in parents
• sleep apnea
• bleeding disorder
• seeking fertility
• 2 or more cardiovascular risk factors: smoking, hypertension, diabetes, dyslipidemias, family history of cardiovascular disease before age 60.
• history of previous cardiovascular event: myocardial infarction, unstable angina, cerebro-vascular accident.
• illicit drug use/alcohol use (>4 drinks per day)

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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