Body Composition Assessment in Spinal Cord Injury

Sponsor

Hunter Holmes Mcguire Veteran Affairs Medical Center (U.S. Fed)

Overall Status

Unknown status

CT.gov ID

NCT00957762

Collaborator

(none)

170

Enrollment

Location

Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

Study Type:

Observational

Anticipated Enrollment :

170 participants

Time Perspective:

Prospective

Official Title:

Body Composition Assessment in Spinal Cord Injury

Study Start Date :

Aug 1, 2009

Anticipated Primary Completion Date :

Sep 1, 2012

Anticipated Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	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

Arm

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

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.