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Clinical Trials/NCT02062307
NCT02062307
Completed
Not Applicable

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

Gulhane School of Medicine1 site in 1 country92 target enrollmentAugust 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypogonadotropic Hypogonadism
Sponsor
Gulhane School of Medicine
Enrollment
92
Locations
1
Primary Endpoint
Osteoprotegerin, Fibroblast Growth Factor 23 and Vitamin D3 levels
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2012
End Date
August 2013
Last Updated
12 years ago
Study Type
Observational
Sex
Male

Investigators

Sponsor
Gulhane School of Medicine
Responsible Party
Principal Investigator
Principal Investigator

Coskun Meric

MD

Gulhane School of Medicine

Eligibility Criteria

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

Outcomes

Primary Outcomes

Osteoprotegerin, Fibroblast Growth Factor 23 and Vitamin D3 levels

Time Frame: one year

investigate the markers of bone mineral metabolism in patients with hypogonadism

Secondary Outcomes

  • relationship between bone mineral metabolism and endothelial dysfunction, insulin resistance(one year)

Study Sites (1)

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