- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00253279
Alterations in Protein Synthesis Rates of Burn Patients Measured Over Time Using PET Scans
A Quantitative Study of the Metabolic Alterations in Protein Synthesis Rate That Occur in Burn Patients Over the Time Course of Their Injury Using Positron Emission Tomography.
Study Overview
Detailed Description
The purpose of this study is to understand how muscles are built up and broken down (metabolism) in both burn patients and healthy people.The studies will help us understand how muscle metabolism is different for burn patients and healthy subjects. We hope to find ways to help the body of a burn victim heal without losing too much muscle.
Protein is an important part of our daily diet. Normally, the body breaks down the protein we eat into smaller pieces called amino acids. It uses the amino acids to make its own proteins. It uses these proteins to heal wounds, fight infections, and provide energy.
After a burn injury, the body speeds up the pace of its life activities. It needs more energy just to stay alive and recover from the burn. The body often gets the extra energy it needs by breaking the protein in muscles down into amino acids. The amino acids are then made into new proteins. If too much muscle is broken down, it is harder for the body to function. This can make recovery slower or possibly lead to death.
For Healthy Volunteers, this study will require no more than 6 hours of time in total. This time will be spread out over two visits, a Screening Visit and a Scan Visit.
For Burn Patients, this study will require no more than 14 hours total. This time will be spread out over four visits-a screening visit and a maximum of 3 scan visits. A total of three PET scans will be done over a 2 year period.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Contact:
- Mary-Liz C Bilodeau, MS
- Phone Number: 617-726-8766
- Email: mbilodeau@partners.org
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Contact:
- Yong-Ming Yu, MD, PhD
- Phone Number: 617-724-7766
- Email: yyu@partners.org
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Principal Investigator:
- Alan J Fischman, MD, PhD
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Sub-Investigator:
- Colleen M Ryan, MD
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Sub-Investigator:
- Robert L Sheridan, MD
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Sub-Investigator:
- Shawn P Fagan, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
FOR HEALTHY VOLUNTEERS
Healthy males and females 18-70 years of age.
Laboratory results within MGH-accepted normal range.
Within 20% of the ideal weight for their height.
Supine and standing blood pressure within the range of 110/60 to 150/90 mm Hg
Heart rate within the range of 46-90 beats/minute after 5 minutes of rest.
Subjects <40 years old with HCT >=24, age 40-60 with HCT >=27, age 60-70 with HCT >=30.
FOR BURN SUBJECTS:
Inclusion Criteria:
Burn Injury of >=5 % TBSA from any cause.
18 -70 years of age
Stable hemodynamic and cardiopulmonary states as judged by the attending surgeons in the burn unit.
Patient who is capable of giving full informed consent.
Exclusion Criteria:
FOR HEALTHY SUBJECTS Clinical evidence of physical or mental disease.
Clinically significant abnormality of the laboratory tests.
Known drug or alcohol dependence.
History of drug allergy
Taking standard prescription drugs within two weeks or investigational drugs within four weeks prior to the PET scan
Diabetes mellitus and other metabolic endocrine disorders Pregnant or lactating
FOR BURN SUBJECTS:
Pregnant or lactating females
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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1
16 healthy subjects will be studied.
Each patient will undergo one PET Scan to measure muscle protein synthesis rate.
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Healthy volunteers will undergo one PET Scan; bur patients will undergo a maximum of 3 PET scans over 2 years after injury; a maximum of 2 will be done while inpatient; one after d/c.
Other Names:
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2
48 burn patients will be studied.
Each patient will have a maximum of 3 PET Scans, which will be done at different times during the first 24 months after injury.
A maximum of 2 of these scans will be done while they are inpatient; one after discharge.
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Healthy volunteers will undergo one PET Scan; bur patients will undergo a maximum of 3 PET scans over 2 years after injury; a maximum of 2 will be done while inpatient; one after d/c.
Other Names:
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ronald T Tompkins, MD, ScD, Massachusetts General Hospital, Shriners Burn Hospital- Boston
Publications and helpful links
General Publications
- Fischman AJ, Hsu H, Carter EA, Yu YM, Tompkins RG, Guerrero JL, Young VR, Alpert NM. Regional measurement of canine skeletal muscle blood flow by positron emission tomography with H2(15)O. J Appl Physiol (1985). 2002 Apr;92(4):1709-16. doi: 10.1152/japplphysiol.00445.2001.
- Fischman AJ, Yu YM, Livni E, Babich JW, Young VR, Alpert NM, Tompkins RG. Muscle protein synthesis by positron-emission tomography with L-[methyl-11C]methionine in adult humans. Proc Natl Acad Sci U S A. 1998 Oct 27;95(22):12793-8. doi: 10.1073/pnas.95.22.12793.
- Hsu H, Yu YM, Babich JW, Burke JF, Livni E, Tompkins RG, Young VR, Alpert NM, Fischman AJ. Measurement of muscle protein synthesis by positron emission tomography with L-[methyl-11C]methionine. Proc Natl Acad Sci U S A. 1996 Mar 5;93(5):1841-6. doi: 10.1073/pnas.93.5.1841.
- Carter EA, Yu YM, Alpert NM, Bonab AA, Tompkins RG, Fischman AJ. Measurement of muscle protein synthesis by positron emission tomography with L-[methyl-11C]methionine: effects of transamination and transmethylation. J Trauma. 1999 Aug;47(2):341-5. doi: 10.1097/00005373-199908000-00021.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2005-P-001510
- G P50 GM021700-28
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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