Bone Mineral Markers in Hypogonadism

Insulin Resistance Clinical Trial

Official title:

Osteoprotegerin, Fibroblast Growth Factor 23 and Vitamin D3 Levels in Male Patients With Hypogonadism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02062307
• Other study ID #: cmeric2000
• Status: Completed
• Phase: N/A
• First received: February 12, 2014
• Last updated: February 12, 2014
• Start date: August 2012
• Est. completion date: August 2013

Study information

• Verified date: February 2014
• Source: Gulhane School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Hypogonadism
• Hypogonadotropic Hypogonadism
• Insulin Resistance

Locations

Country	Name	City	State
Turkey	Gulhane School of Medicine	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gulhane School of Medicine

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Osteoprotegerin, Fibroblast Growth Factor 23 and Vitamin D3 levels	investigate the markers of bone mineral metabolism in patients with hypogonadism	one year	No
Secondary	relationship between bone mineral metabolism and endothelial dysfunction, insulin resistance		one year	No