Body Composition Assessment in Spinal Cord Injury
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Hunter Holmes Mcguire Veteran Affairs Medical Center.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Hunter Holmes Mcguire Veteran Affairs Medical Center
Information provided by:
Hunter Holmes Mcguire Veteran Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00957762
First received: August 5, 2009
Last updated: August 11, 2009
Last verified: August 2009
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Purpose
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| 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:
|
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Genders Eligible for Study: | Both |
| 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).
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.
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 ClinicalTrials.gov identifier: NCT00957762
Please refer to this study by its ClinicalTrials.gov identifier: NCT00957762
Contacts
| Contact: Joshua Miller, MS | 804-675-6200 | Joshua.Miller@va.gov |
Locations
| 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 | |
Sponsors and Collaborators
Hunter Holmes Mcguire Veteran Affairs Medical Center
Investigators
| 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 |
| ClinicalTrials.gov Identifier: | NCT00957762 History of Changes |
| Other Study ID Numbers: | B6232I HM12090 |
| Study First Received: | August 5, 2009 |
| Last Updated: | August 11, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by Hunter Holmes Mcguire Veteran Affairs Medical Center:
|
Body Composition Glucose Tolerance Insulin Sensitivity Metabolic Syndrome |
Additional relevant MeSH terms:
|
Diabetes Mellitus Wounds and Injuries Spinal Cord Injuries Quadriplegia Paraplegia Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Paralysis Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on September 23, 2016