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Body Composition Assessment in Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT00957762
Recruitment Status : Unknown
Verified August 2009 by Hunter Holmes Mcguire Veteran Affairs Medical Center.
Recruitment status was:  Recruiting
First Posted : August 12, 2009
Last Update Posted : August 12, 2009
Sponsor:
Information provided by:
Hunter Holmes Mcguire Veteran Affairs Medical Center

Study Description
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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).

Condition or disease Intervention/treatment
Diabetes Mellitus Body Composition Tetraplegia Paraplegia Spinal Cord Injury Other: Body composition

Detailed Description:
A preliminary investigation in our laboratory has demonstrated the advantage of using 4-compartment modeling to assess body composition in SCI adults. In comparing body composition analyses techniques in 20 individuals with SCI, we found Total Error to be 8.0% with Dual X-ray Absorptiometry, 8.4% with hydrodensitometry, 11.5% with bioelectrical impedance analysis, and 21.8% with standard skinfold equations when compared to 4-compartment modeling, the currently accepted gold standard for body composition assessment. To date there is no gold standard for the determination of body composition in SCI individuals.
Study Design
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Study Type : Observational
Estimated Enrollment : 170 participants
Time Perspective: Prospective
Official Title: Body Composition Assessment in Spinal Cord Injury
Study Start Date : August 2009
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Other: Body composition
Day 1 testing will incorporate underwater weighing, Bod Pod, DXA, BIA and anthropometrics. Day 2 will include RMR, MRI, and testing at GCRC
Other Names:
  • Spinal Cord Injury
  • Percentage body fat


Outcome Measures
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Primary Outcome Measures :
  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. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. 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) [ Time Frame: 3 years ]
  2. 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. [ Time Frame: 3 years ]
  3. To cross-validate the derived regression equations against the gold standard 4-compartment model in an independent group of persons with SCI. [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals with a spinal cord injury of C5-L2 motor complete (AIS A&B only).
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00957762


Contacts
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Contact: Joshua Miller, MS 804-675-6200 Joshua.Miller@va.gov

Locations
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United States, Virginia
Hunter Holmes McGuire Spinal Cord Injury Research Lab Recruiting
Richmond, Virginia, United States, 23249
Contact: Joshua Miller, MS    804-675-6200    Joshua.Miller@va.gov   
Sponsors and Collaborators
Hunter Holmes Mcguire Veteran Affairs Medical Center
Investigators
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Principal Investigator: David R Gater, MD, PhD Hunter Holmes McGuire VAMC
More Information
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Responsible Party: David R Gater MD, Ph D, Hunter Holmes McGuire VA
ClinicalTrials.gov Identifier: NCT00957762    
Other Study ID Numbers: B6232I
HM12090
First Posted: August 12, 2009    Key Record Dates
Last Update Posted: August 12, 2009
Last Verified: August 2009
Keywords provided by Hunter Holmes Mcguire Veteran Affairs Medical Center:
Body Composition
Glucose Tolerance
Insulin Sensitivity
Metabolic Syndrome
Additional relevant MeSH terms:
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Spinal Cord Injuries
Paraplegia
Quadriplegia
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Paralysis
Neurologic Manifestations