Development of a Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients
This trial is active, not recruiting.
|Sponsor||The University of Texas Medical Branch, Galveston|
|Start date||October 2009|
|End date||October 2015|
|Trial size||20 participants|
|Trial identifier||NCT00994669, 09-150B, 5R01CA127971|
The long-term objective of this research is to develop a non-invasive approach for early assessment of which patients are at high risk for future development of skeletal muscle atrophy. The investigators hypothesize that the rate constant for the terminal portion of the isotope decay curve following ingestion of a single oral dose of deuterated-3-methylhistidine (D-3MH) provides an accurate measure of this increased risk and that this rate constant can be measured non-invasively from timed spot urine samples. In addition, the investigators hypothesize that ingestion of a meat-containing meal will stimulate synthesis of skeletal muscle proteins to a greater extent than a non-meat-containing meal.
|Observational model||case control|
Assessment of the slope of terminal D-3MH/3MH decay curve post-dosing.
time frame: Post-dosing 12 to 22 hours
Male participants from 30 years up to 85 years old.
Inclusion Criteria: - male - 30-85 years - Body Mass Index (BMI) <30 kg/m2 Exclusion Criteria: - Uncontrolled hypertension - Glomerular filtration rate less than 60 mL/min/1.73 m2 - History of recurrent gastrointestinal bleeding - Unable or unwilling to provide informed consent - Ongoing anti-coagulant therapy
|Official title||Development of a Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients|
|Principal investigator||Melinda Sheffield-Moore, Ph.D.|
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