Bone Mineral Markers in Hypogonadism

February 12, 2014 updated by: Coskun Meric, Gulhane School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

92

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06018
        • Gulhane School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

The study group was selected from the male subjects with hypogonadotropic hypogonadism who were not previously given testosterone or human chorionic gonadotropin therapy. The patients did not have any chronic metabolic disorders or organ dysfunction. Forty three age and BMI matched male volunteers were enrolled as control subjects.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
control patients
BMI and age matched healthy male subjects
hypogonadism patients
unconfounded group of patients with hypogonadism

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Osteoprotegerin, Fibroblast Growth Factor 23 and Vitamin D3 levels
Time Frame: one year
investigate the markers of bone mineral metabolism in patients with hypogonadism
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
relationship between bone mineral metabolism and endothelial dysfunction, insulin resistance
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gulhane School of Medicine

Investigators

  • Principal Investigator: Coskun Meric, Gulhane School of Medicine Department of Endocrinology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

February 12, 2014

First Submitted That Met QC Criteria

February 12, 2014

First Posted (Estimate)

February 13, 2014

Study Record Updates

Last Update Posted (Estimate)

February 13, 2014

Last Update Submitted That Met QC Criteria

February 12, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cmeric2000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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