Bone Mineral Markers in Hypogonadism

Completed

• Conditions: Endothelial Dysfunction; Insulin Resistance; Hypogonadotropic Hypogonadism

• Registration Number: NCT02062307
• Lead Sponsor: Gulhane School of Medicine

Brief Summary

The aim of this study is to investigate the markers of bone mineral metabolism in an unconfounded group of patients with hypogonadism and to search for a relationship between endothelial dysfunction and insulin resistance.

Detailed Description

Cardiometabolic disorders are prevalent in patients with hypogonadism. Endothelial dysfunction and insulin resistance are used in determining cardiovascular risk. The role of markers of bone mineral metabolism in hypogonadism is not clearly presented.

49 male patients with hypogonadotropic hypogonadism (HH) and 43 BMI and age matched healthy male subjects were enrolled. Osteoprotegerin (OPG), fibroblast growth factor-23 (FGF-23), vitamin D and asymmetric dimethylarginine (ADMA) levels were measured. The insulin sensitivity was estimated by homeostatic model assessment-insulin resistance (HOMA-IR) formula.

Study Timeline

• Study Start: 2012-08
• Primary Completion: 2013-07
• Study Completion: 2013-08
• Status Verified: 2014-02
• Study First Submitted: 2014-02-12
• Study First Submitted QC: 2014-02-12
• Last Update Submitted: 2014-02-12
• Study First Posted: 2014-02-13
• Last Update Posted: 2014-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 92

Inclusion Criteria

• male patients with hypogonadotropic hypogonadism
• being under the age of 45 and over the age of 18
• not previously given testosterone or human chorionic gonadotropin therapy
• not have any chronic metabolic disorders or organ dysfunction

Exclusion Criteria

• female patients
• Other reasons hipogondism
• receive any treatment of hypogonadism
• presence of comorbid diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Osteoprotegerin, Fibroblast Growth Factor 23 and Vitamin D3 levels	one year	investigate the markers of bone mineral metabolism in patients with hypogonadism

Secondary Outcome Measures

Name	Time	Method
relationship between bone mineral metabolism and endothelial dysfunction, insulin resistance	one year

Trial Locations

Locations (1)

Gulhane School of Medicine; 🇹🇷 Ankara, Turkey