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Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients

Sponsor
The University of Texas Medical Branch, Galveston (Other)
Overall Status
Completed
CT.gov ID
NCT01015274
Collaborator
(none)
10
Enrollment
1
Location

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    10 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients
    Study Start Date :
    Oct 1, 2009

    Arms and Interventions

    Arm Intervention/Treatment
    Healthy control male

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      30 Years to 75 Years
      Sexes Eligible for Study:
      Male
      Accepts Healthy Volunteers:
      Yes
      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

      Locations

      Site City State Country Postal Code
      1 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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      The University of Texas Medical Branch, Galveston
      ClinicalTrials.gov Identifier:
      NCT01015274
      Other Study ID Numbers:
      • 09-150
      • 1R43AR054993-01A,
      • AR054993
      • 1R43AR054993-01
      First Posted:
      Nov 18, 2009
      Last Update Posted:
      Jul 11, 2018
      Last Verified:
      Jul 1, 2011
      Additional relevant MeSH terms:
      Cachexia

      Study Results

      No Results Posted as of Jul 11, 2018