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

Hypogonadotrophic Hypogonadism Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02171390
• Other study ID #: GSM-042014
• Status: Completed
• Phase: Phase 4
• First received: June 20, 2014
• Last updated: June 20, 2014
• Start date: August 2008

Study information

• Verified date: March 2014
• Source: Gulhane School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Central Ethical Committee
• Study type: Interventional

Clinical Trial Summary

The study searched for answers to two questions

1. Is there endothelial dysfunction, inflammation and insulin resistance in patients with congenital hypogonadotropic hypogonadism?

2. What is the effect of testosterone replacement therapy on endothelial dysfunction, inflammation and insulin resistance?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 26 Years

Eligibility

Inclusion Criteria:

• Men

• Treatment naive

• Hypogonadotrophic hypogonadism

Exclusion Criteria:

• Previous history of androgen replacement

• Chronic metabolic disorders

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypogonadism
• Hypogonadotrophic Hypogonadism
• Inflammation
• Insulin Resistance

Intervention

Drug:
• Testosterone 250mg injection
The testosterone 250mg ester intramuscular injections performed in three weeks
• Testosteron 50 mg transdermal gel
50mg testosterone gel implemented on every night

Locations

Country	Name	City	State
Turkey	Gulhane School of Medicine Department of Endocrinology and Metabolism	Ankara	NonUS

Sponsors (1)

Lead Sponsor	Collaborator
Gulhane School of Medicine

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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.	No