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Completed

NCT Number: NCT02062307

Bone Mineral Markers in Hypogonadism

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.

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Key information

Conditions

Hypogonadotropic Hypogonadism Endocrine System Diseases Endothelial Dysfunction Glucose Metabolism Disorders Gonadal Disorders Hyperinsulinism Hypogonadism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Observational

Primary location

Gulhane School of Medicine

Ankara, 06018, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  1. relationship between bone mineral metabolism and endothelial dysfunction, insulin resistance

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Gulhane School of Medicine

Other

Registry information

Official study title

Osteoprotegerin, Fibroblast Growth Factor 23 and Vitamin D3 Levels in Male Patients With Hypogonadism

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 13, 2014
Registry last updated
Feb 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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