Lipolytic Effects of GH in Human Subjects in Vivo

Study Overview
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Brief Summary
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Growth hormone (GH) induces fat metabolism. The mechanisms underlying the fat metabolizing effects of GH remain elusive. However, it is known that insulin suppresses fat metabolism, and GH inhibits the expression of certain insulin-dependent signaling proteins. We therefore hypothesize that the fat metabolizing effects of GH depend on abrogation of insulin-dependent signaling pathways. In order to investigate the fat metabolizing effects of GH, we'll analyze consecutive adipose tissue biopsies taken after GH exposure and GH blocking, respectively. Knowledge of the effects of growth hormone and fat metabolism can in shot-sight as well as in long-sight have great importance for the understanding of growth disorders from overweight and type 2 diabetes to malnutrition and eating disorders.

Official Title
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Lipolytic Effects of GH in Human Subjects in Vivo: Molecular Mechanisms and Temporal Patterns

Conditions
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Metabolic Diseases, Growth Hormone Treatment

Intervention / Treatment
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* Drug: Growth Hormone
* Drug: Pegisomant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy males no medication BMI 28-35 Exclusion Criteria: known diseases regular medication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Growth hormone<br>Subjects are receiving growth hormone | Drug: Growth Hormone<br>* Subjects are receiving one injection of growth hormone (Genotropin) 0,5 mg<br>* Other names: Genotropin;|
| Placebo Comparator: Placebo<br>Subjects are receiving pegvisomant to block the action of growth hormone | Drug: Pegisomant<br>* One the placebo day the subjects are receiving injection with pegvisomant (Somavert 30 mg) to block the action of endogenous growth hormone<br>* Other names: Somavert;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipolytic activity measured as area under the curve (AUC) for FFA (blood sample). |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Substrate metabolism as measured by indirect calorimetry |  | 3 months | 
| GH signaling proteins in adipose tissue measured by western blotting |  | 1,5 years | 
| Intracellular lipolytic activity measured by an ATGL assay |  | 1 year | 
| GH signaling gene targets in adipose tissue measured by qPCR |  | 1,5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lipolysis, ATGL