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Trial record 1 of 1 for:    NCT00476879
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Growth Hormone During Fasting.Signaltransduktion in Muscle and Adipose Tissue and Changes in Intrahepatic Lipid Content

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ClinicalTrials.gov Identifier: NCT00476879
Recruitment Status : Completed
First Posted : May 22, 2007
Last Update Posted : August 12, 2008
Sponsor:
Collaborators:
Aarhus University Hospital
Pfizer
Information provided by:
University of Aarhus

Tracking Information
First Submitted Date  ICMJE May 21, 2007
First Posted Date  ICMJE May 22, 2007
Last Update Posted Date August 12, 2008
Study Start Date  ICMJE August 2006
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2008)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 21, 2007)
  • 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2007)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Growth Hormone During Fasting.Signaltransduktion in Muscle and Adipose Tissue and Changes in Intrahepatic Lipid Content
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Metabolism
  • Fatty Liver
Intervention  ICMJE Drug: Somatropin and pegvisomant
Somatropin are given intravenous, 0.5mg pegvisomant are given subcutaneous, 15 mg NaCl are given subcutaneous, 2 ml
Study Arms  ICMJE
  • 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
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 21, 2007)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00476879
Other Study ID Numbers  ICMJE 090600-deleted
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jens Otto Lunde Jorgensen, Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Aarhus
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE
  • Aarhus University Hospital
  • Pfizer
Investigators  ICMJE
Principal Investigator: Louise Moller, MD Medical department M, Aarhus Sygehus, Norrebrogade 44, 8000 Aarhus, Denmark
PRS Account University of Aarhus
Verification Date August 2008

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