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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypogonadotropic Hypogonadism, Kallmann Syndrome

Intervention / Treatment
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* Drug: Anastrozole Pill
* Drug: Testosterone
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Androgen only addback<br>Anastrozole 10 mg orally once daily for 3 months Testosterone gel 7.5 g transdermally daily for 3 months. | Drug: Anastrozole Pill<br>* 10 mg of Anastrozole to be taken daily for 3 months.<br>* Other names: Arimidex (anastrozole);Drug: Testosterone<br>* Androgel 7.5 g to be applied transdermally daily for 3 months.<br>* Other names: Androgel;|
| Experimental: Combined sex steroid addback<br>Placebo (sugar pill) tablet once daily for 3 months Testosterone gel 7.5 g transdermally daily for 3 months. | Drug: Testosterone<br>* Androgel 7.5 g to be applied transdermally daily for 3 months.<br>* Other names: Androgel;Drug: Placebo Oral Tablet<br>* One tablet to be taken daily for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glucose tolerance | Response to 75 g glucose load | Change between baseline and 3 months | 
| Change in insulin sensitivity | IV glucose tolerance test | Change between baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in visceral fat | Assessed by CT of abdomen | Change between baseline and 3 months | 
| Change in resting energy expenditure | Assessed by metabolic monitor | Change between baseline and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IHH, KS, Idiopathic hypogonadotropic hypogonadism, GnRH deficiency