Growth Hormone During Fasting.Signaltransduktion in Muscle and Adipose Tissue and Changes in Intrahepatic Lipid Content

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the effects of growth hormone during fasting in healthy lean men.

Detailed Description
-----------------
During fasting the human body is known to metabolize relatively large amounts of fat, in the expense of proteins and glucose. Partly this shift in metabolism is caused by increasing GH secretion, but exactly how growth hormone exerts these effects remains to be further investigated. 10 healthy lean young men are studied at 4 different occasions in a randomized single-blinded cross-over study. 1: after 12 hours of fasting + GH bolus, 2: after 36 hours of fasting + GH bolus, 3: after 36 hours + saline, 4: after 36 hours of fasting + Somavert. Aim: to study the signal transduction in muscle and fat tissue to study the metabolism during fasting to study the intrahepatic fat content using magnetic resonance techniques

Official Title
-----------------
Growth Hormone During Fasting. Signaltransduktion in Muscle and Adipose Tissue, Consequence of Growth Hormone Receptor Antagonist, Quantification of Intrahepatic Lipid Content Based on MR Scanning

Conditions
-----------------
Metabolism, Fatty Liver

Intervention / Treatment
-----------------
* Drug: Somatropin and pegvisomant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male healthy age 20 - 40 years of age BMI 20 -25 Exclusion Criteria: uses any medication drinks more than 21 units of alcohol per is claustrophobic carries any magnetic devices

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>12 hours of fasting and a GH bolus | Drug: Somatropin and pegvisomant<br>* Somatropin are given intravenous, 0.5mg pegvisomant are given subcutaneous, 15 mg NaCl are given subcutaneous, 2 ml<br>|
| Experimental: 2<br>36 hours of fasting and a GH bolus | Drug: Somatropin and pegvisomant<br>* Somatropin are given intravenous, 0.5mg pegvisomant are given subcutaneous, 15 mg NaCl are given subcutaneous, 2 ml<br>|
| Experimental: 3<br>36 hours of fasting and Pegvisomant | Drug: Somatropin and pegvisomant<br>* Somatropin are given intravenous, 0.5mg pegvisomant are given subcutaneous, 15 mg NaCl are given subcutaneous, 2 ml<br>|
| Experimental: 4<br>36 hours of fasting and NaCl injection | Drug: Somatropin and pegvisomant<br>* Somatropin are given intravenous, 0.5mg pegvisomant are given subcutaneous, 15 mg NaCl are given subcutaneous, 2 ml<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in intrahepatic lipid content |  | 12 and 36 hours of fasting. respectively | 
| changes in intracellular signaling during fasting |  | 36 hours | 
| changes in respiratory quotient |  | 36 hours of fasting | 
| metabolism |  | 36 hours of fasting | 
| insulin sensitivity |  | 36 hours of fasting | 
| forearm metabolism |  | 36 hours of fasting | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in FFA |  | 36 hours of fasting | 
| Changes in grelin |  | 36 hours of fasting | 
| changes in leptin, adiponektin, cortisol, catecholamine, glucagon, carbamide, palmitate |  | 36 hours of fasting | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Growth hormone, Fasting, Signaltransduction, fatty liver, insulin sensitivity, forearm model, protein metabolism, respiratory quotient