Body Composition Assessment in Spinal Cord Injury

Diabetes Mellitus Clinical Trial

Official title:

Body Composition Assessment in Spinal Cord Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00957762
• Other study ID #: B6232I
• Secondary ID: HM12090
• Status: Recruiting
• Phase: N/A
• First received: August 5, 2009
• Last updated: August 11, 2009
• Start date: August 2009
• Est. completion date: October 2012

Study information

• Verified date: August 2009
• Source: Hunter Holmes Mcguire Veteran Affairs Medical Center
• Contact: Joshua Miller, MS
• Phone: 804-675-6200
• Email: Joshua.Miller[@]va.gov
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: October 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Body Composition
• Diabetes Mellitus
• Paraplegia
• Spinal Cord Injuries
• Spinal Cord Injury
• Tetraplegia

Intervention

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

Locations

Country	Name	City	State
United States	Hunter Holmes McGuire Spinal Cord Injury Research Lab	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Hunter Holmes Mcguire Veteran Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	To cross-validate the derived regression equations against the gold standard 4-compartment model in an independent group of persons with SCI.		3 years	No