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Growth Hormone During Fasting.Signaltransduktion in Muscle and Adipose Tissue and Changes in Intrahepatic Lipid Content
This study has been completed.
Sponsor:
University of Aarhus
Collaborators:
Aarhus University Hospital
Pfizer
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00476879
First received: May 21, 2007
Last updated: August 11, 2008
Last verified: August 2008
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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 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 |
Resource links provided by NLM:
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 ]
- 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 ]
Secondary Outcome Measures:
- 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 ]
| 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) |
| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00476879
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):
| 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 |
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 August 23, 2017