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
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
  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:
  • 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
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

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

No publications provided

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:
Spinal Cord Injuries
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries
Diabetes Mellitus
Paraplegia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Central Nervous System Diseases
Nervous System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014