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Plasma RBP Levels in Patients With Idiopathic Hypogonadotrophic Hypogonadism

Sponsor
Gulhane School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT01758094
Collaborator
(none)
25
Enrollment
1
Location
55
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the present study was to demonstrate the RBP4 levels, association of RBP4 with insulin resistance and influence of testosterone treatment on this cytokine in patients with idiopathic hypogonadotropic hypogonadism.

Condition or Disease Intervention/Treatment Phase
  • Drug: Sustanon 250 mg ampule (Testosterone esters)

Study Design

Study Type:
Observational
Actual Enrollment :
25 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Study Start Date :
Jan 1, 2008
Actual Primary Completion Date :
Aug 1, 2012
Actual Study Completion Date :
Aug 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Hypogonadotropic hypogonadism patients

Treatment naive 25 patients with idiopathic hypogonadotrophic hypogonadism

Drug: Sustanon 250 mg ampule (Testosterone esters)
Drug used for treatment of hypogonadism
Other Names:
  • No name

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Retinol binding protein 4, hs-CRP levels in patients with idiopathic hypogonadotrophic hypogonadism [2008-2012]

    Secondary Outcome Measures

    1. Effect of testosterone treatment on retinol binding globulin 4 and hs-CRP levels in patients with hypogodotrophic hypogonadism [2008-2012]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 26 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    decreased serum testosterone concentration below the normal range (serum T < 300ng/dL), FSH and LH levels within or below the normal range, absence of a pituitary or hypothalamic mass lesions on MRI, presence of gonadotropin response to repetitive doses of GnRH, normal smell test and normal karyotypes

    Exclusion Criteria:

    previous androgen treatment, history of smoking, presence of bilateral anorchia, intellectual deficiency, diabetes mellitus, arterial hypertension or dyslipoproteinemia, medication of any kind and drug abuse. Because of possible confounding effects, patients with other hormone deficiencies were excluded.

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gulhane School of Medicine Dep. of Endocrinology and Metabolism Ankara Turkey 06018

    Sponsors and Collaborators

    • Gulhane School of Medicine

    Investigators

    • Study Director: Aydogan Aydogdu, MD, Gulhane School of Medicine, Department of Endocrinology and Metabolism

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aydogan Aydogdu, MD, Gulhane School of Medicine
    ClinicalTrials.gov Identifier:
    NCT01758094
    Other Study ID Numbers:
    • 24122012
    First Posted:
    Jan 1, 2013
    Last Update Posted:
    Jan 3, 2013
    Last Verified:
    Jan 1, 2013
    Keywords provided by Aydogan Aydogdu, MD, Gulhane School of Medicine
    hypogonadism
    Retinol binding globulin 4
    Testosterone treatment
    Additional relevant MeSH terms:
    Hypogonadism
    Testosterone

    Study Results

    No Results Posted as of Jan 3, 2013