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Body Composition Assessment in Spinal Cord Injury

Body Composition Assessment in Spinal Cord Injury

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00957762
Enrollment
170
Registered
2009-08-12
Start date
2009-08-31
Completion date
2012-10-31
Last updated
2009-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Body Composition, Glucose Tolerance, Insulin Sensitivity, Metabolic Syndrome

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.

Interventions

OTHERBody composition

Day 1 testing will incorporate underwater weighing, Bod Pod, DXA, BIA and anthropometrics. Day 2 will include RMR, MRI, and testing at GCRC

Sponsors

Hunter Holmes Mcguire Veteran Affairs Medical Center
Lead SponsorFED

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Countries

United States

Contacts

Primary ContactJoshua Miller, MS
Joshua.Miller@va.gov804-675-6200

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026