MetabolismNCT00476879
Growth Hormone During Fasting.Signaltransduktion in Muscle and Adipose Tissue and Changes in Intrahepatic Lipid Content
A study testing Somatropin and pegvisomant in people with Metabolism and Fatty Liver, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to examine the effects of growth hormone during fasting in healthy lean men. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolism, Fatty Liver
- What is being tested?
- Somatropin and pegvisomant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2006to Jun 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male
- healthy
- age 20 - 40 years of age
- BMI 20 -25
Who cannot join
- uses any medication
- drinks more than 21 units of alcohol per
- is claustrophobic
- carries any magnetic devices
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Medical department M, Arhus Sygehus, Region midtjylland
Aarhus, 8000
About this study
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
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
- Conditions
- Metabolism, Fatty Liver
- Being tested
- Somatropin and pegvisomant
- Keywords
- Growth hormone, Fasting, Signaltransduction, fatty liver, insulin sensitivity, forearm model, protein metabolism, respiratory quotient
- Medical subject headings
- Fatty Liver, Fasting, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somatropin and pegvisomantDrug
Somatropin are given intravenous, 0.5mg pegvisomant are given subcutaneous, 15 mg NaCl are given subcutaneous, 2 ml
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 12 hours of fasting and a GH bolus Receives: Drug: Somatropin and pegvisomant |
| 2 | Experimental | 36 hours of fasting and a GH bolus Receives: Drug: Somatropin and pegvisomant |
| 3 | Experimental | 36 hours of fasting and Pegvisomant Receives: Drug: Somatropin and pegvisomant |
| 4 | Experimental | 36 hours of fasting and NaCl injection Receives: Drug: Somatropin and pegvisomant |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in intrahepatic lipid content
Measured: 12 and 36 hours of fasting. respectively
changes in intracellular signaling during fasting
Measured: 36 hours
changes in respiratory quotient
Measured: 36 hours of fasting
metabolism
Measured: 36 hours of fasting
insulin sensitivity
Measured: 36 hours of fasting
forearm metabolism
Measured: 36 hours of fasting
Secondary outcomes (3)
changes in FFA
Measured: 36 hours of fasting
Changes in grelin
Measured: 36 hours of fasting
changes in leptin, adiponektin, cortisol, catecholamine, glucagon, carbamide, palmitate
Measured: 36 hours of fasting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2007 (estimated)
- Study startAug 2006
- Primary completionNov 2007
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MetabolismStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Pfizer
- Investigators
- Louise Moller, MD, Principal investigator, Medical department M, Aarhus Sygehus, Norrebrogade 44, 8000 Aarhus, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00476879
- Sponsor's protocol ID
- 090600-deleted
- Status last verified
- Aug 2008
- First submitted
- 21 May 2007
- Last updated
- 12 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00476879
- Acronym / sponsor ID
- 090600-deleted
- Conditions
- Metabolism, Fatty Liver
- Keywords
- Growth hormone, Fasting, Signaltransduction, fatty liver, insulin sensitivity, forearm model, protein metabolism, respiratory quotient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Pfizer
- Study start
- Aug 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 22 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effects of growth hormone during fasting in healthy lean men.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Somatropin and pegvisomant12 hours of fasting and a GH bolus |
| 2 | Experimental | Drug: Somatropin and pegvisomant36 hours of fasting and a GH bolus |
| 3 | Experimental | Drug: Somatropin and pegvisomant36 hours of fasting and Pegvisomant |
| 4 | Experimental | Drug: Somatropin and pegvisomant36 hours of fasting and NaCl injection |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- male
- healthy
- age 20 - 40 years of age
- BMI 20 -25
Key exclusion criteria (4 listed)
- uses any medication
- drinks more than 21 units of alcohol per
- is claustrophobic
- carries any magnetic devices
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Somatropin and pegvisomantSomatropin are given intravenous, 0.5mg pegvisomant are given subcutaneous, 15 mg NaCl are given subcutaneous, 2 ml | Drug | 1, 2, 3, 4 |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2008.
- Derived from this study: PubMed 19820031Moller 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise Moller, MD principal investigator
Medical department M, Aarhus Sygehus, Norrebrogade 44, 8000 Aarhus, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Somatropin and pegvisomant in people with Metabolism and Fatty Liver, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in intrahepatic lipid content (time frame: 12 and 36 hours of fasting. respectively). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00476879, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2008.