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

This study has been completed.
Sponsor:
Collaborators:
Aarhus University Hospital
Pfizer
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00476879
First received: May 21, 2007
Last updated: August 11, 2008
Last verified: August 2008
History of Changes
  Purpose

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


Condition Intervention
Metabolism
Fatty Liver
 Drug: Somatropin and pegvisomant

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • changes in intrahepatic lipid content [ Time Frame: 12 and 36 hours of fasting. respectively ] [ Designated as safety issue: No ]
  • changes in intracellular signaling during fasting [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
  • changes in respiratory quotient [ Time Frame: 36 hours of fasting ] [ Designated as safety issue: No ]
  • metabolism [ Time Frame: 36 hours of fasting ] [ Designated as safety issue: No ]
  • insulin sensitivity [ Time Frame: 36 hours of fasting ] [ Designated as safety issue: No ]
  • forearm metabolism [ Time Frame: 36 hours of fasting ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • changes in FFA [ Time Frame: 36 hours of fasting ] [ Designated as safety issue: No ]
  • Changes in grelin [ Time Frame: 36 hours of fasting ] [ Designated as safety issue: No ]
  • changes in leptin, adiponektin, cortisol, catecholamine, glucagon, carbamide, palmitate [ Time Frame: 36 hours of fasting ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: August 2006
Study Completion Date: June 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
12 hours of fasting and a GH bolus
 Drug: Somatropin and pegvisomant
Somatropin are given intravenous, 0.5mg pegvisomant are given subcutaneous, 15 mg NaCl are given subcutaneous, 2 ml
Experimental: 2
36 hours of fasting and a GH bolus
 Drug: Somatropin and pegvisomant
Somatropin are given intravenous, 0.5mg pegvisomant are given subcutaneous, 15 mg NaCl are given subcutaneous, 2 ml
Experimental: 3
36 hours of fasting and Pegvisomant
 Drug: Somatropin and pegvisomant
Somatropin are given intravenous, 0.5mg pegvisomant are given subcutaneous, 15 mg NaCl are given subcutaneous, 2 ml
Experimental: 4
36 hours of fasting and NaCl injection
 Drug: Somatropin and pegvisomant
Somatropin are given intravenous, 0.5mg pegvisomant are given subcutaneous, 15 mg NaCl are given subcutaneous, 2 ml

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
  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00476879

Locations
Denmark
Medical department M, Arhus Sygehus, Region midtjylland
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Pfizer
Investigators
Principal Investigator: Louise Moller, MD Medical department M, Aarhus Sygehus, Norrebrogade 44, 8000 Aarhus, Denmark
  More Information

No publications provided by University of Aarhus

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jens Otto Lunde Jorgensen, Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Aarhus
ClinicalTrials.gov Identifier: NCT00476879     History of Changes
Other Study ID Numbers: 090600-deleted
Study First Received: May 21, 2007
Last Updated: August 11, 2008
Health Authority: Denmark: Ethics Committee

Keywords provided by University of Aarhus:
Growth hormone
Fasting
Signaltransduction
fatty liver
 insulin sensitivity
forearm model
protein metabolism
respiratory quotient

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013