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NCT Number: NCT00613288

Testosterone and Lipolysis, Insulin Sensitivity and Protein Metabolism

Testosterone(T) has known effects on many organ systems, although many of its metabolic actions are unrevealed. T is an anabolic hormone stimulating protein synthesis but this effect has barely been investigated in controlled studies. It also has lipolytic actions influencing body composition, but little is known of its regional impact on fat tissue. T affects insulin sensitivity. There is an increased incidence of hypogonadism in type 2 diabetes, and among patients with hypogonadism there is an increased incidence of type 2 diabetes. The actions of testosterone on glucose metabolism are unknown.

The purpose of this study is therefore to:

Investigate the lipolytic effect of testosterone on muscle and fat tissue. To gain insight in the intracellular mechanisms of testosterone on lipolysis and investigate possible regional differences in lipolysis and changes in body composition.

Finally to investigate the effect of short term experimental hypogonadism and acute testosterone substitution on cytokines, insulin sensitivity and protein metabolism.

The trial is a randomised double blinded cross-over study of 4 x 2 days with an interval of 1 month in between. 12 healthy young men will receive GnRH treatment over a 3 month period and examined on 4 occasions with various degrees of T substitution and placebo . The examinations take place at the Research Lab within the Medical Department M.

The investigations are deemed relevant to the understanding of the interrelationship between male hypogonadism and type 2 diabetes. The hypothesis is that T has beneficial effects on carbohydrate, fat and protein metabolism. The generated knowledge would therefore hopefully improve prophylaxis, screening and early treatment of both group of patients.

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Key information

Age range

20 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Medical department M and Investigational Laboratories

Aarhus C, Jutland, 8000, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male, age 20-35
  • Normal biochemical screen and ECG

Exclusion criteria

  • Heart disease
  • BMI>25
  • Diabetes
  • Antecedent or present cancer
  • Vascular disease
  • Antecedent or present hormone treatment
  • Medical treatment with known effects on fat metabolism
  • Big X-ray examinations equivalent to, or more than a chest x-ray and all kinds of CT scans until 6 month before the start of the study and during the study.

Treatment and study plan

Testosterone (Testogel), GnRH analog (Leuprorelide) and Placebo

Drug

The trial is a double blinded, randomised cross-over study of 4 x 2 days with an interval of 1 month in between. 12 healthy young male participants will receive the GnRH-agonist leuprorelide 7,5 mg s.c. 3 weeks before examination on 3 occasions, and a fourth day without intervention.

The four days will include treatment on the examination day, Day 1 with:

  • Placebo (hypogonadism after leuprorelide injection)
  • Testosterone gel 50 mg applicated in the morning at 06.00 am (physiologic substitution - after leuprorelide injection).
  • Testosterone gel 150 mg applicated in the morning at 06.00 am (supra-physiologic substitution - after leuprorelide injection).
  • No treatment.

Primary outcomes

  1. Testosterone influence on Insulin Sensitivity, Lipolysis and protein metabolism

    Time frame: 4-6 month pr patient

Secondary outcomes

  1. Testosterone influence on Body composition by DEXA scan, Energy expenditure by indirect Calorimetry and VO2 max test

    Time frame: 4-6 month pr patient

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 13, 2008
Registry last updated
Oct 22, 2009

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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