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Trial record 3 of 3 for:    "Hypogonadism" | "Vitamin D3"

Bone Mineral Markers in Hypogonadism

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ClinicalTrials.gov Identifier: NCT02062307
Recruitment Status : Completed
First Posted : February 13, 2014
Last Update Posted : February 13, 2014
Sponsor:
Information provided by (Responsible Party):
Coskun Meric, Gulhane School of Medicine

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
Hypogonadotropic Hypogonadism Endothelial Dysfunction Insulin Resistance

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.


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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 : August 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals Vitamin D

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



Primary Outcome Measures :
  1. Osteoprotegerin, Fibroblast Growth Factor 23 and Vitamin D3 levels [ Time Frame: 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 [ Time Frame: one year ]

Biospecimen Retention:   Samples Without DNA
Serum and plasma samples


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02062307


Locations
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Turkey
Gulhane School of Medicine
Ankara, Turkey, 06018
Sponsors and Collaborators
Gulhane School of Medicine
Investigators
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Principal Investigator: Coskun Meric Gulhane School of Medicine Department of Endocrinology

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Responsible Party: Coskun Meric, MD, Gulhane School of Medicine
ClinicalTrials.gov Identifier: NCT02062307     History of Changes
Other Study ID Numbers: cmeric2000
First Posted: February 13, 2014    Key Record Dates
Last Update Posted: February 13, 2014
Last Verified: February 2014
Keywords provided by Coskun Meric, Gulhane School of Medicine:
Hypogonadism
Asymmetric Dimethyl Arginine
Osteoprotegerin
Fibroblast Growth Factor
Vitamin D
Additional relevant MeSH terms:
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Hypogonadism
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Gonadal Disorders
Endocrine System Diseases
Vitamin D
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents