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

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Ages Eligible for Study: | 20 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00476879
Denmark | |
Medical department M, Arhus Sygehus, Region midtjylland | |
Aarhus, Denmark, 8000 |
Principal Investigator: | Louise Moller, MD | Medical department M, Aarhus Sygehus, Norrebrogade 44, 8000 Aarhus, Denmark |
Responsible Party: | Jens Otto Lunde Jorgensen, Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Aarhus |
ClinicalTrials.gov Identifier: | NCT00476879 |
Other Study ID Numbers: |
090600-deleted |
First Posted: | May 22, 2007 Key Record Dates |
Last Update Posted: | August 12, 2008 |
Last Verified: | August 2008 |
Growth hormone Fasting Signaltransduction fatty liver |
insulin sensitivity forearm model protein metabolism respiratory quotient |
Fatty Liver Liver Diseases Digestive System Diseases |