Body Composition Assessment in Spinal Cord Injury
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ClinicalTrials.gov Identifier: NCT00957762 |
Recruitment Status : Unknown
Verified August 2009 by Hunter Holmes Mcguire Veteran Affairs Medical Center.
Recruitment status was: Recruiting
First Posted : August 12, 2009
Last Update Posted : August 12, 2009
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Condition or disease | Intervention/treatment |
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Diabetes Mellitus Body Composition Tetraplegia Paraplegia Spinal Cord Injury | Other: Body composition |
Study Type : | Observational |
Estimated Enrollment : | 170 participants |
Time Perspective: | Prospective |
Official Title: | Body Composition Assessment in Spinal Cord Injury |
Study Start Date : | August 2009 |
Estimated Primary Completion Date : | September 2012 |
Estimated Study Completion Date : | October 2012 |

Group/Cohort | Intervention/treatment |
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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.
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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:
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- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00957762
Contact: Joshua Miller, MS | 804-675-6200 | Joshua.Miller@va.gov |
United States, Virginia | |
Hunter Holmes McGuire Spinal Cord Injury Research Lab | Recruiting |
Richmond, Virginia, United States, 23249 | |
Contact: Joshua Miller, MS 804-675-6200 Joshua.Miller@va.gov |
Principal Investigator: | David R Gater, MD, PhD | Hunter Holmes McGuire VAMC |
Responsible Party: | David R Gater MD, Ph D, Hunter Holmes McGuire VA |
ClinicalTrials.gov Identifier: | NCT00957762 |
Other Study ID Numbers: |
B6232I HM12090 |
First Posted: | August 12, 2009 Key Record Dates |
Last Update Posted: | August 12, 2009 |
Last Verified: | August 2009 |
Body Composition Glucose Tolerance Insulin Sensitivity Metabolic Syndrome |
Spinal Cord Injuries Paraplegia Quadriplegia Wounds and Injuries Spinal Cord Diseases |
Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Paralysis Neurologic Manifestations |