Body Composition Assessment in Spinal Cord Injury

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Body Composition Assessment in Spinal Cord Injury

Conditions
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Diabetes Mellitus, Body Composition, Tetraplegia, Paraplegia, Spinal Cord Injury

Intervention / Treatment
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* Other: Body composition


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Body Composition<br>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<br>* Day 1 testing will incorporate underwater weighing, Bod Pod, DXA, BIA and anthropometrics. Day 2 will include RMR, MRI, and testing at GCRC<br>* Other names: Percentage body fat;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Body Composition, Glucose Tolerance, Insulin Sensitivity, Metabolic Syndrome