Growth Hormone During Fasting.Signaltransduktion in Muscle and Adipose Tissue and Changes in Intrahepatic Lipid Content - Full Text View

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:

MedlinePlus related topics: Hormones

Drug Information available for: Somatropin Pegvisomant

Genetic and Rare Diseases Information Center resources: Visceral Steatosis

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 (Adult)
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

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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

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

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.


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

ClinicalTrials.gov processed this record on September 26, 2016