Body Composition Assessment in Spinal Cord Injury
2 other identifiers
observational
170
1 country
1
Brief Summary
The purpose of this research is to evaluate different methods of measuring body composition (amount of fat, muscle, bone, and water in your body) and to determine relationships between body composition and other medical problems associated with spinal cord injury (SCI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2009
Typical duration for all trials
1 active site
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
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 5, 2009
CompletedFirst Posted
Study publicly available on registry
August 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedAugust 12, 2009
August 1, 2009
3.1 years
August 5, 2009
August 11, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare different methods of body composition analyses with the gold standard 4-compartment monitoring to determine accuracy and validity of those alternative, but less labor-intensive techniques.
3 years
Secondary Outcomes (3)
To assess the relationship between % body fat, visceral fat, and markers of the metabolic syndrome, including Plasminogen Activator Inhibitor-1 (PAI-1), Thrombin-Activatable Fibrinolysis Inhibitor (TAFI), and high-sensitivity C-Reactive Protein (hsCRP)
3 years
To develop body composition regression equations that can be easily utilized in a clinical setting to estimate risk for the metabolic syndrome in persons with SCI.
3 years
To cross-validate the derived regression equations against the gold standard 4-compartment model in an independent group of persons with SCI.
3 years
Study Arms (1)
Body Composition
120 subjects will help create the regression models. The remaining 50 subjects will be recruited to determine if the equations work for the population.
Interventions
Day 1 testing will incorporate underwater weighing, Bod Pod, DXA, BIA and anthropometrics. Day 2 will include RMR, MRI, and testing at GCRC
Eligibility Criteria
Individuals with a spinal cord injury of C5-L2 motor complete (AIS A\&B only).
You may qualify if:
- Criteria for participation will include men and women within the age range of 18-65 years old with C5-L2 Motor-Complete (ASIA A\&B)
- SCI of duration greater than 12 months to ensure a homogenous sample.
You may not qualify if:
- Persons with uncompensated hypothyroidism, and/or renal disease will be excluded from the study.
- Additionally, individuals with uncontrolled autonomic dysreflexia, recent (within 3 months) deep vein thrombosis
- Pressure ulcers \> Grade II will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hunter Holmes McGuire Spinal Cord Injury Research Lab
Richmond, Virginia, 23249, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David R Gater, MD, PhD
Hunter Holmes McGuire VAMC
Central Study Contacts
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- FED
Study Record Dates
First Submitted
August 5, 2009
First Posted
August 12, 2009
Study Start
August 1, 2009
Primary Completion
September 1, 2012
Study Completion
October 1, 2012
Last Updated
August 12, 2009
Record last verified: 2009-08