NCT01015274

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2009

Completed
Last Updated

July 11, 2018

Status Verified

July 1, 2011

First QC Date

November 16, 2009

Last Update Submit

July 9, 2018

Conditions

Cachexia

Study Arms (1)

Healthy control male

Eligibility Criteria

Age30 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

community sample of healthy males

You may qualify if:

  • Male
  • years old
  • Body Mass Index (BMI) \<27 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

  • Morteza Janghorbani, Ph.D.

    BIOCHEMANALYSIS CORPORATION

    PRINCIPAL INVESTIGATOR

  • Melinda Sheffield-Moore, Ph.D.

    University of Texas

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 16, 2009

First Posted

November 18, 2009

Study Start

October 1, 2009

Last Updated

July 11, 2018

Record last verified: 2011-07

Locations

US(1)