Skip to main content
OpenTrials
Completed

NCT Number: NCT02171390

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

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?

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypogonadotrophic Hypogonadism Endocrine System Diseases Glucose Metabolism Disorders Gonadal Disorders Hyperinsulinism Hypogonadism Inflammation Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–26 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Gulhane School of Medicine Department of Endocrinology and Metabolism

Ankara, NonUS, 06018, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men
  • Treatment naive
  • Hypogonadotrophic hypogonadism

Exclusion criteria

  • Previous history of androgen replacement
  • Chronic metabolic disorders

Treatment and study plan

Testosterone 250mg injection

Drug

The testosterone 250mg ester intramuscular injections performed in three weeks

Other names: Sustanon 250 mg amp.

Testosteron 50 mg transdermal gel

Drug

50mg testosterone gel implemented on every night

Other names: Testogel 50mg transdermal gel

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Gulhane School of Medicine

Other

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2012
First posted
Jun 24, 2014
Registry last updated
Jun 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.