Back to resultsEndothelial Dysfunction, Inflammation and Insulin Resistance in Congenital Hypogonadism and Effect of Testosteron Replacement Therapy
Primary Purpose
Hypogonadotrophic Hypogonadism
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Testosterone 250mg injection
Testosteron 50 mg transdermal gel
Sponsored by
About this trial
This is an interventional treatment trial for Hypogonadotrophic Hypogonadism focused on measuring Hypogonadism, Endothelial dysfunction, Insulin resistance, Inflammation, Testosterone replacement therapy
Eligibility Criteria
Inclusion Criteria:
- Men
- Treatment naive
- Hypogonadotrophic hypogonadism
Exclusion Criteria:
- Previous history of androgen replacement
- Chronic metabolic disorders
Sites / Locations
- Gulhane School of Medicine Department of Endocrinology and Metabolism
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Daily testosterone transdermal gel
Injectable Testosterone esters
Arm Description
Testosteron 250mg injection per 3-4 weeks for 6 months
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02171390
First Posted
June 20, 2014
Last Updated
June 20, 2014
Sponsor
Gulhane School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02171390
Brief Title
Endothelial Dysfunction, Inflammation and Insulin Resistance in Congenital Hypogonadism and Effect of Testosteron Replacement Therapy
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 Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gulhane School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadotrophic Hypogonadism
Keywords
Hypogonadism, Endothelial dysfunction, Insulin resistance, Inflammation, Testosterone replacement therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Daily testosterone transdermal gel
Arm Type
Active Comparator
Arm Title
Injectable Testosterone esters
Arm Type
Active Comparator
Arm Description
Testosteron 250mg injection per 3-4 weeks for 6 months
Intervention Type
Drug
Intervention Name(s)
Testosterone 250mg injection
Other Intervention Name(s)
Sustanon 250 mg amp.
Intervention Description
The testosterone 250mg ester intramuscular injections performed in three weeks
Intervention Type
Drug
Intervention Name(s)
Testosteron 50 mg transdermal gel
Other Intervention Name(s)
Testogel 50mg transdermal gel
Intervention Description
50mg testosterone gel implemented on every night
Primary Outcome Measure Information:
Title
The alterations in the measures for endothelial functions
Description
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.
Time Frame
6 months
Title
The alterations in the measures of inflammation
Description
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.
Time Frame
6 months
Title
The alterations in the measures of insulin resistance
Description
The alterations in insulin sensitivity are estimated by using the homeostasis model assessment (HOMA) index by the formula, HOMA = (insulin x glucose)/405.
Time Frame
6 months.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Men
Treatment naive
Hypogonadotrophic hypogonadism
Exclusion Criteria:
Previous history of androgen replacement
Chronic metabolic disorders
Facility Information:
Facility Name
Gulhane School of Medicine Department of Endocrinology and Metabolism
City
Ankara
State/Province
NonUS
ZIP/Postal Code
06018
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Endothelial Dysfunction, Inflammation and Insulin Resistance in Congenital Hypogonadism and Effect of Testosteron Replacement Therapy
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