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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Metabolism; Fatty Liver	Drug: Somatropin and pegvisomant	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	10 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	August 2006
Actual Primary Completion Date :	November 2007
Actual Study Completion Date :	June 2008

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

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 Outcome Measures :

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 ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	20 Years to 40 Years (Adult)
Sexes 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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	May 22, 2007
Last Update Posted:	August 12, 2008
Last Verified:	August 2008

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