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Body Composition Assessment in Spinal Cord Injury

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by Hunter Holmes Mcguire Veteran Affairs Medical Center.
Recruitment status was:  Recruiting
Information provided by:
Hunter Holmes Mcguire Veteran Affairs Medical Center Identifier:
First received: August 5, 2009
Last updated: August 11, 2009
Last verified: August 2009
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 Intervention
Diabetes Mellitus Body Composition Tetraplegia Paraplegia Spinal Cord Injury Other: Body composition

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Body Composition Assessment in Spinal Cord Injury

Resource links provided by NLM:

Further study details as provided by Hunter Holmes Mcguire Veteran Affairs Medical Center:

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. [ Time Frame: 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) [ Time Frame: 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. [ Time Frame: 3 years ]
  • To cross-validate the derived regression equations against the gold standard 4-compartment model in an independent group of persons with SCI. [ Time Frame: 3 years ]

Estimated Enrollment: 170
Study Start Date: August 2009
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals with a spinal cord injury of C5-L2 motor complete (AIS A&B only).

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00957762

Contact: Joshua Miller, MS 804-675-6200

United States, Virginia
Hunter Holmes McGuire Spinal Cord Injury Research Lab Recruiting
Richmond, Virginia, United States, 23249
Contact: Joshua Miller, MS    804-675-6200   
Sponsors and Collaborators
Hunter Holmes Mcguire Veteran Affairs Medical Center
Principal Investigator: David R Gater, MD, PhD Hunter Holmes McGuire VAMC
  More Information

Responsible Party: David R Gater MD, Ph D, Hunter Holmes McGuire VA Identifier: NCT00957762     History of Changes
Other Study ID Numbers: B6232I
Study First Received: August 5, 2009
Last Updated: August 11, 2009

Keywords provided by Hunter Holmes Mcguire Veteran Affairs Medical Center:
Body Composition
Glucose Tolerance
Insulin Sensitivity
Metabolic Syndrome

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Trauma, Nervous System
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms processed this record on September 19, 2017