Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients

This study has been completed.
Information provided by:
The University of Texas, Galveston Identifier:
First received: November 16, 2009
Last updated: July 13, 2011
Last verified: July 2011

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.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients

Further study details as provided by The University of Texas, Galveston:

Estimated Enrollment: 10
Study Start Date: October 2009
Healthy control male


Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

community sample of healthy males


Inclusion Criteria:

  • Male
  • 30-75 years old
  • Body Mass Index (BMI) <27 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01015274

United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Sponsors and Collaborators
The University of Texas, Galveston
Principal Investigator: Morteza Janghorbani, Ph.D. BIOCHEMANALYSIS CORPORATION
Study Director: Melinda Sheffield-Moore, Ph.D. University of Texas
  More Information

No publications provided

Responsible Party: Morteza Janghorbani, Ph.D., BIOCHEMANALYSIS CORPORATION, Chicago, IL Identifier: NCT01015274     History of Changes
Other Study ID Numbers: 09-150, 1R43AR054993-01A,, AR054993
Study First Received: November 16, 2009
Last Updated: July 13, 2011
Health Authority: United States: Institutional Review Board processed this record on February 27, 2015