Endothelial Dysfunction, Inflammation and Insulin Resistance in Congenital Hypogonadism and Effect of Testosteron Replacement Therapy

Study Overview
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Brief Summary
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The study searched for answers to two questions Is there endothelial dysfunction, inflammation and insulin resistance in patients with congenital hypogonadotropic hypogonadism? What is the effect of testosterone replacement therapy on endothelial dysfunction, inflammation and insulin resistance?

Official Title
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Phase 4 Study That Evaluates the Presence of Endothelial Dysfunction, Inflammation and Insulin Resistance in Male Subjects With Hypogonadotrophic Hypogonadism and Effects of Two Different Testosterone Replacement Regiments on These Parameters.

Conditions
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Hypogonadotrophic Hypogonadism

Intervention / Treatment
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* Drug: Testosterone 250mg injection
* Drug: Testosteron 50 mg transdermal gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men Treatment naive Hypogonadotrophic hypogonadism Exclusion Criteria: Previous history of androgen replacement Chronic metabolic disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Daily testosterone transdermal gel<br> | Drug: Testosteron 50 mg transdermal gel<br>* 50mg testosterone gel implemented on every night<br>* Other names: Testogel 50mg transdermal gel;|
| Active Comparator: Injectable Testosterone esters<br>Testosteron 250mg injection per 3-4 weeks for 6 months | Drug: Testosterone 250mg injection<br>* The testosterone 250mg ester intramuscular injections performed in three weeks<br>* Other names: Sustanon 250 mg amp.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The alterations in the measures for endothelial functions | The alterations in Endothelial functions are determined by measuring plasma asymmetric dimethylarginine (ADMA) levels, as a surrogate. ADMA measurement is performed by ELISA kit (Immunodiagnostic, Bernheim, Germany)(Catalog Number 7828) with a minimal detection limit of 0.05µmol/L. | 6 months | 
| The alterations in the measures of inflammation | The alterations in the measures of inflammation are determined by measuring plasma TWEAK levels. ELISA kit (Bender MedSystems, Lot Nr.BMS2006INST, Vienna, Austria) was used. | 6 months | 
| The alterations in the measures of insulin resistance | The alterations in insulin sensitivity are estimated by using the homeostasis model assessment (HOMA) index by the formula, HOMA = (insulin x glucose)/405. | 6 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypogonadism, Endothelial dysfunction, Insulin resistance, Inflammation, Testosterone replacement therapy