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

Phase 1TerminatedNCT03118479

Massachusetts General Hospital7 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Hypogonadotropic Hypogonadism Kallmann Syndrome

Interventions

Anastrozole PillDRUG

10 mg of Anastrozole to be taken daily for 3 months.

TestosteroneDRUG

Androgel 7.5 g to be applied transdermally daily for 3 months.

Placebo Oral TabletDRUG

One tablet to be taken daily for 3 months

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Change in glucose tolerance

Response to 75 g glucose load

Time frame: Change between baseline and 3 months

Change in insulin sensitivity

IV glucose tolerance test

Time frame: Change between baseline and 3 months

Secondary Outcomes

Change in visceral fat

Assessed by CT of abdomen

Time frame: Change between baseline and 3 months

Change in resting energy expenditure

Assessed by metabolic monitor

Time frame: Change between baseline and 3 months

Data from ClinicalTrials.gov

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