Testosterone and Lipolysis, Insulin Sensitivity and Protein Metabolism

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00613288
First received: January 31, 2008
Last updated: October 21, 2009
Last verified: October 2009
  Purpose

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 Intervention
Hypogonadism
Drug: Testosterone (Testogel), GnRH analog (Leuprorelide) and Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Testosterone and Lipolysis, Insulin Sensitivity and Protein Metabolism

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Testosterone influence on Insulin Sensitivity, Lipolysis and protein metabolism [ Time Frame: 4-6 month pr patient ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Testosterone influence on Body composition by DEXA scan, Energy expenditure by indirect Calorimetry and VO2 max test [ Time Frame: 4-6 month pr patient ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: September 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A 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.

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00613288

Locations
Denmark
Medical department M and Investigational Laboratories
Aarhus C, Jutland, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Jens S Christensen, Professor Medical Department M, Aarhus University Hospital, Denmark
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MD, PhD, DMSc Claus H. Gravholt, Medical Departmnt M, Endocrinology and Diabetes, Aarus University Hospital, NBG
ClinicalTrials.gov Identifier: NCT00613288     History of Changes
Other Study ID Numbers: M-20070046
Study First Received: January 31, 2008
Last Updated: October 21, 2009
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by University of Aarhus:
acute
testosterone
experimental
hypogonadism
lipolysis
insulin sensitivity
protein
metabolism
Experimental hypogonadism
Testosterone substitution

Additional relevant MeSH terms:
Hypogonadism
Insulin Resistance
Gonadal Disorders
Endocrine System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Insulin
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents
Hypoglycemic Agents

ClinicalTrials.gov processed this record on August 01, 2014