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

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02171390

Enrollment

130

Registered

2014-06-24

Start date

2008-08-31

Completion date

Unknown

Last updated

2014-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypogonadotrophic Hypogonadism

Keywords

Hypogonadism, Endothelial dysfunction, Insulin resistance, Inflammation, Testosterone replacement therapy

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?

Interventions

DRUGTestosterone 250mg injection

The testosterone 250mg ester intramuscular injections performed in three weeks

DRUGTestosteron 50 mg transdermal gel

50mg testosterone gel implemented on every night

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 26 Years

Healthy volunteers

Yes

Inclusion criteria

* Men * Treatment naive * Hypogonadotrophic hypogonadism

Exclusion criteria

* Previous history of androgen replacement * Chronic metabolic disorders

Design outcomes

Primary

Measure	Time frame	Description
The alterations in the measures for endothelial functions	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	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	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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026