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

Primary Purpose

Metabolism, Fatty Liver

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Somatropin and pegvisomant
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metabolism focused on measuring Growth hormone, Fasting, Signaltransduction, fatty liver, insulin sensitivity, forearm model, protein metabolism, respiratory quotient

Eligibility Criteria

20 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Medical department M, Arhus Sygehus, Region midtjylland

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

Arm Description

12 hours of fasting and a GH bolus

36 hours of fasting and a GH bolus

36 hours of fasting and Pegvisomant

36 hours of fasting and NaCl injection

Outcomes

Primary Outcome Measures

changes in intrahepatic lipid content
changes in intracellular signaling during fasting
changes in respiratory quotient
metabolism
insulin sensitivity
forearm metabolism

Secondary Outcome Measures

changes in FFA
Changes in grelin
changes in leptin, adiponektin, cortisol, catecholamine, glucagon, carbamide, palmitate

Full Information

First Posted
May 21, 2007
Last Updated
August 11, 2008
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00476879
Brief Title
Growth Hormone During Fasting.Signaltransduktion in Muscle and Adipose Tissue and Changes in Intrahepatic Lipid Content
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolism, Fatty Liver
Keywords
Growth hormone, Fasting, Signaltransduction, fatty liver, insulin sensitivity, forearm model, protein metabolism, respiratory quotient

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
12 hours of fasting and a GH bolus
Arm Title
2
Arm Type
Experimental
Arm Description
36 hours of fasting and a GH bolus
Arm Title
3
Arm Type
Experimental
Arm Description
36 hours of fasting and Pegvisomant
Arm Title
4
Arm Type
Experimental
Arm Description
36 hours of fasting and NaCl injection
Intervention Type
Drug
Intervention Name(s)
Somatropin and pegvisomant
Intervention Description
Somatropin are given intravenous, 0.5mg pegvisomant are given subcutaneous, 15 mg NaCl are given subcutaneous, 2 ml
Primary Outcome Measure Information:
Title
changes in intrahepatic lipid content
Time Frame
12 and 36 hours of fasting. respectively
Title
changes in intracellular signaling during fasting
Time Frame
36 hours
Title
changes in respiratory quotient
Time Frame
36 hours of fasting
Title
metabolism
Time Frame
36 hours of fasting
Title
insulin sensitivity
Time Frame
36 hours of fasting
Title
forearm metabolism
Time Frame
36 hours of fasting
Secondary Outcome Measure Information:
Title
changes in FFA
Time Frame
36 hours of fasting
Title
Changes in grelin
Time Frame
36 hours of fasting
Title
changes in leptin, adiponektin, cortisol, catecholamine, glucagon, carbamide, palmitate
Time Frame
36 hours of fasting

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louise Moller, MD
Organizational Affiliation
Medical department M, Aarhus Sygehus, Norrebrogade 44, 8000 Aarhus, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical department M, Arhus Sygehus, Region midtjylland
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
19820031
Citation
Moller L, Norrelund H, Jessen N, Flyvbjerg A, Pedersen SB, Gaylinn BD, Liu J, Thorner MO, Moller N, Lunde Jorgensen JO. Impact of growth hormone receptor blockade on substrate metabolism during fasting in healthy subjects. J Clin Endocrinol Metab. 2009 Nov;94(11):4524-32. doi: 10.1210/jc.2009-0381. Epub 2009 Oct 9.
Results Reference
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Growth Hormone During Fasting.Signaltransduktion in Muscle and Adipose Tissue and Changes in Intrahepatic Lipid Content

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