Overview

This trial is active, not recruiting.

Condition cachexia
Sponsor The University of Texas Medical Branch, Galveston
Start date October 2009
End date October 2015
Trial size 20 participants
Trial identifier NCT00994669, 09-150B, 5R01CA127971

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. 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm

Primary Outcomes

Measure
Assessment of the slope of terminal D-3MH/3MH decay curve post-dosing.
time frame: Post-dosing 12 to 22 hours

Eligibility Criteria

Male participants from 30 years up to 85 years old.

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

Additional Information

Official title Development of a Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients
Principal investigator Melinda Sheffield-Moore, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by The University of Texas Medical Branch, Galveston.