Plasma RBP Levels in Patients With Idiopathic Hypogonadotrophic Hypogonadism

Idiopathic Hypogonadotropic Hypogonadism Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01758094
• Other study ID #: 24122012
• Status: Completed
• Phase: N/A
• First received: December 24, 2012
• Last updated: January 1, 2013
• Start date: January 2008
• Est. completion date: August 2012

Study information

• Verified date: January 2013
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 26 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypogonadism
• Idiopathic Hypogonadotropic Hypogonadism

Intervention

Drug:
• Sustanon 250 mg ampule (Testosterone esters)
Drug used for treatment of hypogonadism

Locations

Country	Name	City	State
Turkey	Gulhane School of Medicine Dep. of Endocrinology and Metabolism	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	Retinol binding protein 4, hs-CRP levels in patients with idiopathic hypogonadotrophic hypogonadism		2008-2012	Yes
Secondary	Effect of testosterone treatment on retinol binding globulin 4 and hs-CRP levels in patients with hypogodotrophic hypogonadism		2008-2012	Yes