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CompletedNCT00476879Updated Aug 12, 2008

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

An interventional study of Somatropin and pegvisomant in Metabolism and Fatty Liver, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to male participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-08-12.

Sponsored by University of Aarhus · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Male
01

Study summary

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

Read the 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
02

Conditions studied

  • Metabolism
  • Fatty Liver

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Keywords

  • Growth hormone
  • Fasting
  • Signaltransduction
  • fatty liver
  • insulin sensitivity
  • forearm model
  • protein metabolism
  • respiratory quotient
03

In context

Fatty Liver

1,451 studies on the registry are indexed under Fatty Liver; 292 are open to participants now.

This study's enrollment of 10 is below the median of 60 across 1,003 interventional studies indexed under Fatty Liver.

Browse Fatty Liver studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • male
  • healthy
  • age 20 - 40 years of age
  • BMI 20 -25

Exclusion criteria

Exclusion Criteria:

  • uses any medication
  • drinks more than 21 units of alcohol per
  • is claustrophobic
  • carries any magnetic devices
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    1

    12 hours of fasting and a GH bolus

    Drug: Somatropin and pegvisomant

  • Experimental
    2

    36 hours of fasting and a GH bolus

    Drug: Somatropin and pegvisomant

  • Experimental
    3

    36 hours of fasting and Pegvisomant

    Drug: Somatropin and pegvisomant

  • Experimental
    4

    36 hours of fasting and NaCl injection

    Drug: Somatropin and pegvisomant

Interventions

  • DrugSomatropin and pegvisomant

    Somatropin are given intravenous, 0.5mg pegvisomant are given subcutaneous, 15 mg NaCl are given subcutaneous, 2 ml

06

What researchers measure

Primary outcomes

  1. changes in intrahepatic lipid content

    Time frame: 12 and 36 hours of fasting. respectively

  2. changes in intracellular signaling during fasting

    Time frame: 36 hours

  3. changes in respiratory quotient

    Time frame: 36 hours of fasting

  4. metabolism

    Time frame: 36 hours of fasting

  5. insulin sensitivity

    Time frame: 36 hours of fasting

  6. forearm metabolism

    Time frame: 36 hours of fasting

Secondary outcomes

  1. changes in FFA

    Time frame: 36 hours of fasting

  2. Changes in grelin

    Time frame: 36 hours of fasting

  3. changes in leptin, adiponektin, cortisol, catecholamine, glucagon, carbamide, palmitate

    Time frame: 36 hours of fasting

07

Study locations

1 site
  • Medical department M, Arhus Sygehus, Region midtjylland
    Aarhus, 8000, Denmark
08

References and documents

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. PubMed 19820031 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00476879
Lead sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Pfizer
First posted
May 22, 2007
Start date
Aug 2006
Primary completion
Nov 2007
Completion
Jun 2008
Last update
Aug 12, 2008

Study contacts

Louise Moller, MD
principal investigator · Medical department M, Aarhus Sygehus, Norrebrogade 44, 8000 Aarhus, Denmark

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.

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