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

Fatty Liver Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00476879
• Other study ID #: 090600-deleted
• Status: Completed
• Phase: N/A
• First received: May 21, 2007
• Last updated: August 11, 2008
• Start date: August 2006
• Est. completion date: June 2008

Study information

• Verified date: August 2008
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the effects of growth hormone during fasting in healthy lean men.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Fatty Liver
• Metabolism

Intervention

Drug:
• Somatropin and pegvisomant
Somatropin are given intravenous, 0.5mg pegvisomant are given subcutaneous, 15 mg NaCl are given subcutaneous, 2 ml

Locations

Country	Name	City	State
Denmark	Medical department M, Arhus Sygehus, Region midtjylland	Aarhus

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, Pfizer

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in intrahepatic lipid content		12 and 36 hours of fasting. respectively	No
Primary	changes in intracellular signaling during fasting		36 hours	No
Primary	changes in respiratory quotient		36 hours of fasting	No
Primary	metabolism		36 hours of fasting	No
Primary	insulin sensitivity		36 hours of fasting	No
Primary	forearm metabolism		36 hours of fasting	No
Secondary	changes in FFA		36 hours of fasting	No
Secondary	Changes in grelin		36 hours of fasting	No
Secondary	changes in leptin, adiponektin, cortisol, catecholamine, glucagon, carbamide, palmitate		36 hours of fasting	No