TerminatedPhase 1

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

Stopped: Because the PI left the institution.

United States7 participantsStarted 2010-05

Plain-language summary

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.

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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)

What they're measuring

Change in glucose tolerance

Timeframe: Change between baseline and 3 months

Change in insulin sensitivity

Timeframe: Change between baseline and 3 months

Trial details

NCT IDNCT03118479

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-09-01

View on ClinicalTrials.gov More Hypogonadotropic Hypogonadism trials