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

Sponsor:

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

History of Changes

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:

MedlinePlus related topics: Spinal Cord Injuries

Genetic and Rare Diseases Information Center resources: Paraplegia

U.S. FDA Resources

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.

Eligibility


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).

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

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

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 21, 2017

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