Testosterone and Lipolysis, Insulin Sensitivity and Protein Metabolism
Information source: University of Aarhus
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypogonadism
Intervention: Testosterone (Testogel), GnRH analog (Leuprorelide) and Placebo (Drug)
Phase: N/A
Status: Completed
Sponsored by: University of Aarhus Official(s) and/or principal investigator(s): Jens S Christensen, Professor, Principal Investigator, Affiliation: Medical Department M, Aarhus University Hospital, Denmark
Summary
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.
Clinical Details
Official title: Testosterone and Lipolysis, Insulin Sensitivity and Protein Metabolism
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Primary outcome: Testosterone influence on Insulin Sensitivity, Lipolysis and protein metabolism
Secondary outcome: Testosterone influence on Body composition by DEXA scan, Energy expenditure by indirect Calorimetry and VO2 max test
Eligibility
Minimum age: 20 Years.
Maximum age: 35 Years.
Gender(s): Male.
Criteria:
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.
Locations and Contacts
Medical department M and Investigational Laboratories, Aarhus C, Jutland 8000, Denmark
Additional Information
Related publications: Malkin CJ, Pugh PJ, Jones RD, Kapoor D, Channer KS, Jones TH. The effect of testosterone replacement on endogenous inflammatory cytokines and lipid profiles in hypogonadal men. J Clin Endocrinol Metab. 2004 Jul;89(7):3313-8.
Starting date: September 2007
Last updated: October 21, 2009
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