Endothelial Dysfunction, Inflammation and Insulin Resistance in Congenital Hypogonadism and Effect of Testosteron Replacement Therapy
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|ClinicalTrials.gov Identifier: NCT02171390|
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : June 24, 2014
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?
|Condition or disease||Intervention/treatment||Phase|
|Hypogonadotrophic Hypogonadism||Drug: Testosterone 250mg injection Drug: Testosteron 50 mg transdermal gel||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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.|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||June 2012|
|Active Comparator: Daily testosterone transdermal gel||
Drug: Testosteron 50 mg transdermal gel
50mg testosterone gel implemented on every night
Other Name: Testogel 50mg transdermal gel
Active Comparator: Injectable Testosterone esters
Testosteron 250mg injection per 3-4 weeks for 6 months
Drug: Testosterone 250mg injection
The testosterone 250mg ester intramuscular injections performed in three weeks
Other Name: Sustanon 250 mg amp.
- The alterations in the measures for endothelial functions [ Time Frame: 6 months ]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.
- The alterations in the measures of inflammation [ Time Frame: 6 months ]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.
- The alterations in the measures of insulin resistance [ Time Frame: 6 months. ]The alterations in insulin sensitivity are estimated by using the homeostasis model assessment (HOMA) index by the formula, HOMA = (insulin x glucose)/405.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02171390
|Gulhane School of Medicine Department of Endocrinology and Metabolism|
|Ankara, NonUS, Turkey, 06018|