Testosterone and Lipolysis, Insulin Sensitivity and Protein Metabolism
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|ClinicalTrials.gov Identifier: NCT00613288|
Recruitment Status : Completed
First Posted : February 13, 2008
Last Update Posted : October 22, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Hypogonadism||Drug: Testosterone (Testogel), GnRH analog (Leuprorelide) and Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Testosterone and Lipolysis, Insulin Sensitivity and Protein Metabolism|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
Drug: Testosterone (Testogel), GnRH analog (Leuprorelide) and Placebo
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:
- Testosterone influence on Insulin Sensitivity, Lipolysis and protein metabolism [ Time Frame: 4-6 month pr patient ]
- Testosterone influence on Body composition by DEXA scan, Energy expenditure by indirect Calorimetry and VO2 max test [ Time Frame: 4-6 month pr patient ]
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): NCT00613288
|Medical department M and Investigational Laboratories|
|Aarhus C, Jutland, Denmark, 8000|
|Principal Investigator:||Jens S Christensen, Professor||Medical Department M, Aarhus University Hospital, Denmark|