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Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01015274
First Posted: November 18, 2009
Last Update Posted: July 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
The University of Texas Medical Branch, Galveston
  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

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

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01015274


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

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
1R43AR054993-01 ( U.S. NIH Grant/Contract )
First Submitted: November 16, 2009
First Posted: November 18, 2009
Last Update Posted: July 14, 2011
Last Verified: July 2011

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