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Testosterone and Lipolysis, Insulin Sensitivity and Protein Metabolism

NCT00613288 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2009-10-22

No results posted yet for this study

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.

Conditions

  • Hypogonadism

Interventions

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: 1. Placebo (hypogonadism after leuprorelide injection) 2. Testosterone gel 50 mg applicated in the morning at 06.00 am (physiologic substitution - after leuprorelide injection). 3. Testosterone gel 150 mg applicated in the morning at 06.00 am (supra-physiologic substitution - after leuprorelide injection). 4. No treatment.

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Jens S Christensen, Professor · Medical Department M, Aarhus University Hospital, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00613288 on ClinicalTrials.gov