NCT00994669

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 14, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

December 4, 2015

Status Verified

December 1, 2015

Enrollment Period

3 years

First QC Date

October 13, 2009

Last Update Submit

December 3, 2015

Conditions

Cachexia

Outcome Measures

Primary Outcomes (1)

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

    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.

    Post-dosing 12 to 22 hours

Study Arms (2)

healthy control male

lung cancer male

Eligibility Criteria

Age30 Years - 85 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

community sample of healthy males and male lung cancer patients

You may qualify if:

  • male
  • years
  • Body Mass Index (BMI) \<30 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Cachexia

Condition Hierarchy (Ancestors)

Weight LossBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinness

Study Officials

  • Melinda Sheffield-Moore, Ph.D.

    University of Texas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2009

First Posted

October 14, 2009

Study Start

October 1, 2009

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

December 4, 2015

Record last verified: 2015-12

Locations

US(1)