Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02171390
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : June 24, 2014
Sponsor:
Information provided by (Responsible Party):
Alper Sonmez, Gulhane School of Medicine

Brief 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?

Condition or disease Intervention/treatment Phase
Hypogonadotrophic Hypogonadism Drug: Testosterone 250mg injection Drug: Testosteron 50 mg transdermal gel Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 26 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men
  • Treatment naive
  • Hypogonadotrophic hypogonadism

Exclusion Criteria:

  • Previous history of androgen replacement
  • Chronic metabolic disorders

Information from the National Library of Medicine

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


Locations
Layout table for location information
Turkey
Gulhane School of Medicine Department of Endocrinology and Metabolism
Ankara, NonUS, Turkey, 06018
Sponsors and Collaborators
Gulhane School of Medicine

Layout table for additonal information
Responsible Party: Alper Sonmez, Associate Professor in Medicine, Gulhane School of Medicine
ClinicalTrials.gov Identifier: NCT02171390     History of Changes
Other Study ID Numbers: GSM-042014
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: June 24, 2014
Last Verified: March 2014
Keywords provided by Alper Sonmez, Gulhane School of Medicine:
Hypogonadism
Endothelial dysfunction
Insulin resistance
Inflammation
Testosterone replacement therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Insulin Resistance
Hypogonadism
Inflammation
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Gonadal Disorders
Endocrine System Diseases
Insulin
Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Hypoglycemic Agents
Physiological Effects of Drugs
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents