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.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- The alterations in the measures for endothelial functions
Study Overview
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?
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 26 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Treatment naive
- •Hypogonadotrophic hypogonadism
Exclusion Criteria
- •Previous history of androgen replacement
- •Chronic metabolic disorders
Arms & Interventions
Injectable Testosterone esters
Testosteron 250mg injection per 3-4 weeks for 6 months
Intervention: Testosterone 250mg injection (Drug)
Daily testosterone transdermal gel
Intervention: Testosteron 50 mg transdermal gel (Drug)
Outcomes
Primary Outcomes
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 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.
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Alper Sonmez
Associate Professor in Medicine
Gulhane School of Medicine