Body Composition Assessment in Spinal Cord Injury

• Conditions: Diabetes Mellitus; Body Composition; Tetraplegia; Paraplegia; Spinal Cord Injury
• Interventions: Other: Body composition

• Registration Number: NCT00957762
• Lead Sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center

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).

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 Timeline

• Status Verified: 2009-08
• Study Start: 2009-08
• Study First Submitted: 2009-08-05
• Study First Submitted QC: 2009-08-11
• Last Update Submitted: 2009-08-11
• Study First Posted: 2009-08-12
• Last Update Posted: 2009-08-12
• Primary Completion: 2012-09
• Study Completion: 2012-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 170

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Body Composition	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To cross-validate the derived regression equations against the gold standard 4-compartment model in an independent group of persons with SCI.	3 years
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

Trial Locations

Locations (1)

Hunter Holmes McGuire Spinal Cord Injury Research Lab; 🇺🇸 Richmond, Virginia, United States