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OpenTrials
Completed

NCT Number: NCT00994669

Development of a Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients

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.

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Key information

Conditions

Cachexia Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms Thinness Weight Loss

Age range

30 year–85 year

Sex eligibility

Male

Study type

Observational

Primary location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Assessment of the slope of terminal D-3MH/3MH decay curve post-dosing.

    Time frame: Post-dosing 12 to 22 hours

    Assess the slope of the terminal D-3MH/3MH decay curve for the post-dosing time period as calculated using plasma or urine samples and after a meat-containing or meat-free test meal.

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Oct 14, 2009
Registry last updated
Dec 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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