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Bone Mineral Markers in Hypogonadism

Sponsor
Gulhane School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT02062307
Collaborator
(none)
92
Enrollment
1
Location
12
Duration (Months)
7.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    92 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Osteoprotegerin, Fibroblast Growth Factor 23 and Vitamin D3 Levels in Male Patients With Hypogonadism
    Study Start Date :
    Aug 1, 2012
    Actual Primary Completion Date :
    Jul 1, 2013
    Actual Study Completion Date :
    Aug 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    control patients

    BMI and age matched healthy male subjects
    hypogonadism patients

    unconfounded group of patients with hypogonadism

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. relationship between bone mineral metabolism and endothelial dysfunction, insulin resistance [one year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gulhane School of Medicine Ankara Turkey 06018

    Sponsors and Collaborators

    • Gulhane School of Medicine

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Coskun Meric, MD, Gulhane School of Medicine
    ClinicalTrials.gov Identifier:
    NCT02062307
    Other Study ID Numbers:
    • cmeric2000
    First Posted:
    Feb 13, 2014
    Last Update Posted:
    Feb 13, 2014
    Last Verified:
    Feb 1, 2014
    Keywords provided by Coskun Meric, MD, Gulhane School of Medicine
    Hypogonadism
    Asymmetric Dimethyl Arginine
    Osteoprotegerin
    Fibroblast Growth Factor
    Vitamin D
    Additional relevant MeSH terms:
    Insulin Resistance
    Hypogonadism

    Study Results

    No Results Posted as of Feb 13, 2014