Clinical trial NCT00957762: Body Composition Assessment in Spinal Cord Injury
Official title: Body Composition Assessment in Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus
Body Composition
Tetraplegia
Paraplegia
Spinal Cord Injury
Keywords: Body Composition
Glucose Tolerance
Insulin Sensitivity
Metabolic Syndrome
Lead sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center
Sponsor class: FED
First posted: 2009-08-12
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with a spinal cord injury of C5-L2 motor complete (AIS A\&B only).

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.

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.

Primary outcomes:
measure: 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.
timeFrame: 3 years
Secondary outcomes:
measure: 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)
timeFrame: 3 years
measure: 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.
timeFrame: 3 years
measure: To cross-validate the derived regression equations against the gold standard 4-compartment model in an independent group of persons with SCI.
timeFrame: 3 years
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Hunter Holmes McGuire Spinal Cord Injury Research Lab
state: Virginia
Study officials:
affiliation: Hunter Holmes McGuire VAMC
name: David R Gater, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: