Plasma RBP Levels in Patients With Idiopathic Hypogonadotrophic Hypogonadism

NCT01758094 | Completed DMC

• 1 other identifier: 24122012
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Hypogonadotropic Hypogonadism

Keywords

hypogonadism; Retinol binding globulin 4; Testosterone treatment

Outcome Measures

Primary Outcomes (1)

• Retinol binding protein 4, hs-CRP levels in patients with idiopathic hypogonadotrophic hypogonadism

  2008-2012

Secondary Outcomes (1)

• Effect of testosterone treatment on retinol binding globulin 4 and hs-CRP levels in patients with hypogodotrophic hypogonadism

  2008-2012

Study Arms (1)

Hypogonadotropic hypogonadism patients

Treatment naive 25 patients with idiopathic hypogonadotrophic hypogonadism

Drug: Sustanon 250 mg ampule (Testosterone esters)

Interventions

Sustanon 250 mg ampule (Testosterone esters) DRUG

Drug used for treatment of hypogonadism

Also known as: No name

Hypogonadotropic hypogonadism patients

Eligibility Criteria

• Age: 19 Years - 26 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients with hypogonadotrophic hypogonadism

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gulhane School of Medicine: lead

Study Sites (1)

Gulhane School of Medicine Dep. of Endocrinology and Metabolism

Ankara, 06018, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Idiopathic Hypogonadotropic Hypogonadism; Hypogonadism

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Aydogan Aydogdu, MD

  Gulhane School of Medicine, Department of Endocrinology and Metabolism

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 24, 2012
• First Posted: January 1, 2013
• Study Start: January 1, 2008
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: January 3, 2013

Record last verified: 2013-01

Locations

TU (1)