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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

May 21, 2007
August 11, 2008
August 2006
November 2007   (final data collection date for primary outcome measure)
  • 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 ]
  • changes in intrahepatic lipid content [ Time Frame: 12 and 36 hours of fasting. respectively ]
  • changes in intracellular signaling during fasting [ Time Frame: 36 hours ]
  • changes in respiratory quotient [ Time Frame: 36 hours of fasting ]
  • metabolism [ Time Frame: 36 hours of fasting ]
  • insulin sensitivity [ Time Frame: 36 hours of fasting ]
  • forearm metabolism [ Time Frame: 36 hours of fasting ]
  • changes in VLDL turnover [ Time Frame: 36 hours of fasting ]
Complete list of historical versions of study NCT00476879 on ClinicalTrials.gov Archive Site
  • 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 ]
  • changes in FFA [ Time Frame: 36 hours of fasting ]
  • Changes in grelin [ Time Frame: 36 hours of fasting ]
  • changes in leptin, adiponektin, cortisol, catecholamine, glucagon, carbamide, palmitate [ Time Frame: 36 hours of fasting ]
Not Provided
Not Provided
 
Growth Hormone During Fasting.Signaltransduktion in Muscle and Adipose Tissue and Changes in Intrahepatic Lipid Content
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

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

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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Metabolism
  • Fatty Liver
Drug: Somatropin and pegvisomant
Somatropin are given intravenous, 0.5mg pegvisomant are given subcutaneous, 15 mg NaCl are given subcutaneous, 2 ml
  • Experimental: 1
    12 hours of fasting and a GH bolus
    Intervention: Drug: Somatropin and pegvisomant
  • Experimental: 2
    36 hours of fasting and a GH bolus
    Intervention: Drug: Somatropin and pegvisomant
  • Experimental: 3
    36 hours of fasting and Pegvisomant
    Intervention: Drug: Somatropin and pegvisomant
  • Experimental: 4
    36 hours of fasting and NaCl injection
    Intervention: Drug: Somatropin and pegvisomant
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. Epub 2009 Oct 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
June 2008
November 2007   (final data collection date for primary outcome measure)

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
Male
20 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00476879
090600-deleted
No
Jens Otto Lunde Jorgensen, Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Aarhus
University of Aarhus
  • Aarhus University Hospital
  • Pfizer
Principal Investigator: Louise Moller, MD Medical department M, Aarhus Sygehus, Norrebrogade 44, 8000 Aarhus, Denmark
University of Aarhus
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP