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Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients

This study has been completed.
Sponsor:
Information provided by:
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT01015274
First received: November 16, 2009
Last updated: July 13, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition
Cachexia

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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

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

  Eligibility

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01015274

Locations
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Sponsors and Collaborators
The University of Texas, Galveston
Investigators
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
ClinicalTrials.gov 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

Additional relevant MeSH terms:
Cachexia
Emaciation
Weight Loss
 Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013