Testosterone and Lipolysis, Insulin Sensitivity and Protein Metabolism
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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 |
- Testosterone influence on Insulin Sensitivity, Lipolysis and protein metabolism [ Time Frame: 4-6 month pr patient ] [ Designated as safety issue: No ]
- 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:
|
Eligibility| Ages Eligible for Study: | 20 Years to 35 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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| Denmark | |
| Medical department M and Investigational Laboratories | |
| Aarhus C, Jutland, Denmark, 8000 | |
| Principal Investigator: | Jens S Christensen, Professor | Medical Department M, Aarhus University Hospital, Denmark |
More Information
Publications:
| 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 May 16, 2013