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

Hypogonadotropic Hypogonadism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03118479
• Other study ID #: 2009 - P - 001874
• Status: Terminated
• Phase: Phase 1
• First received: July 14, 2010
• Last updated: April 17, 2017
• Start date: May 2010
• Est. completion date: September 1, 2010

Study information

• Verified date: April 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: September 1, 2010
• Est. primary completion date: September 1, 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hypogonadism
• Hypogonadotropic Hypogonadism
• Insulin Resistance
• Kallmann Syndrome

Intervention

Drug:
• Anastrozole Pill
10 mg of Anastrozole to be taken daily for 3 months.
• Testosterone
Androgel 7.5 g to be applied transdermally daily for 3 months.
• Placebo Oral Tablet
One tablet to be taken daily for 3 months

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in glucose tolerance	Response to 75 g glucose load	Change between baseline and 3 months
Primary	Change in insulin sensitivity	IV glucose tolerance test	Change between baseline and 3 months
Secondary	Change in visceral fat	Assessed by CT of abdomen	Change between baseline and 3 months
Secondary	Change in resting energy expenditure	Assessed by metabolic monitor	Change between baseline and 3 months