Body Composition Assessment in Spinal Cord Injury

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Brief Title

Body Composition Assessment in Spinal Cord Injury

Official Title

Body Composition Assessment in Spinal Cord Injury

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 Type

Observational


Primary Outcome

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.

Secondary Outcome

 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)

Condition

Diabetes Mellitus

Intervention

Body composition

Study Arms / Comparison Groups

 Body Composition
Description:  120 subjects will help create the regression models. The remaining 50 subjects will be recruited to determine if the equations work for the population.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

170

Start Date

August 2009

Completion Date

October 2012

Primary Completion Date

September 2012

Eligibility 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.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

David R Gater, MD, PhD, 804-675-6200, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00957762

Organization ID

B6232I

Secondary IDs

HM12090


Study Sponsor

Hunter Holmes Mcguire Veteran Affairs Medical Center


Study Sponsor

David R Gater, MD, PhD, Principal Investigator, Hunter Holmes McGuire VAMC


Verification Date

August 2009