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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00994669
Enrollment
17
Registered
2009-10-14
Start date
2009-10-31
Completion date
2012-10-31
Last updated
2015-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cachexia

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. 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.

Interventions

None listed

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
The University of Texas Medical Branch, Galveston
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
30 Years to 85 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Assessment of the slope of terminal D-3MH/3MH decay curve post-dosing.Post-dosing 12 to 22 hoursAssess 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026