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

Phase 1

Terminated

• Conditions: Kallmann Syndrome; Hypogonadotropic Hypogonadism
• Interventions: Drug: Anastrozole Pill; Drug: Testosterone; Drug: Placebo Oral Tablet

• Registration Number: NCT03118479
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-07-14
• Primary Completion: 2010-09-01
• Study Completion: 2010-09-01
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-17
• Last Update Submitted: 2017-04-17
• Study First Posted: 2017-04-18
• Last Update Posted: 2017-04-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 7

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined sex steroid addback	Placebo Oral Tablet	Placebo (sugar pill) tablet once daily for 3 months Testosterone gel 7.5 g transdermally daily for 3 months.
Androgen only addback	Anastrozole Pill	Anastrozole 10 mg orally once daily for 3 months Testosterone gel 7.5 g transdermally daily for 3 months.
Combined sex steroid addback	Testosterone	Placebo (sugar pill) tablet once daily for 3 months Testosterone gel 7.5 g transdermally daily for 3 months.
Androgen only addback	Testosterone	Anastrozole 10 mg orally once daily for 3 months Testosterone gel 7.5 g transdermally daily for 3 months.

Primary Outcome Measures

Name	Time	Method
Change in glucose tolerance	Change between baseline and 3 months	Response to 75 g glucose load
Change in insulin sensitivity	Change between baseline and 3 months	IV glucose tolerance test

Secondary Outcome Measures

Name	Time	Method
Change in visceral fat	Change between baseline and 3 months	Assessed by CT of abdomen
Change in resting energy expenditure	Change between baseline and 3 months	Assessed by metabolic monitor

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States