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

Not Applicable

Completed

• Conditions: Fatty Liver; Metabolism
• Interventions: Drug: Somatropin and pegvisomant

• Registration Number: NCT00476879
• Lead Sponsor: University of Aarhus

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

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2007-05-21
• Study First Submitted QC: 2007-05-21
• Study First Posted: 2007-05-22
• Primary Completion: 2007-11
• Study Completion: 2008-06
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-11
• Last Update Posted: 2008-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Somatropin and pegvisomant	36 hours of fasting and a GH bolus
3	Somatropin and pegvisomant	36 hours of fasting and Pegvisomant
4	Somatropin and pegvisomant	36 hours of fasting and NaCl injection
1	Somatropin and pegvisomant	12 hours of fasting and a GH bolus

Primary Outcome Measures

Name	Time	Method
insulin sensitivity	36 hours of fasting
changes in intrahepatic lipid content	12 and 36 hours of fasting. respectively
changes in respiratory quotient	36 hours of fasting
changes in intracellular signaling during fasting	36 hours
metabolism	36 hours of fasting
forearm metabolism	36 hours of fasting

Secondary Outcome Measures

Name	Time	Method
Changes in grelin	36 hours of fasting
changes in FFA	36 hours of fasting
changes in leptin, adiponektin, cortisol, catecholamine, glucagon, carbamide, palmitate	36 hours of fasting

Trial Locations

Locations (1)

Medical department M, Arhus Sygehus, Region midtjylland; 🇩🇰 Aarhus, Denmark