Recruiting

Observational Study

Sponsor:

Hunter Holmes Mcguire Veteran Affairs Medical Center

Code:

NCT00957762

Conditions

Diabetes Mellitus

Body Composition

Tetraplegia

Paraplegia

Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Body composition

Study Details

Brief summary:

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).

Conditions

Diabetes Mellitus

Body Composition

Tetraplegia

Paraplegia

Spinal Cord Injury

Study ID

NCT00957762

Start date

Aug, 2009

Status verified date

Aug, 2009

Completion date

Oct, 2012

Anticipated

Primary completion date

Sep, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

170 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Joshua Miller, MS

804-675-6200Joshua.Miller@va.gov

Locations

Hunter Holmes McGuire Spinal Cord Injury Research Lab

Recruiting

Richmond, Virginia, United States, 23249

Contacts

Joshua Miller, MS

804-675-6200Joshua.Miller@va.gov

More Information

Sponsor

Hunter Holmes Mcguire Veteran Affairs Medical Center

Last update posted

Aug 12, 2009

Last verified

Aug, 2009

Keywords

  • Body Composition
  • Glucose Tolerance
  • Insulin Sensitivity
  • Metabolic Syndrome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hunter Holmes Mcguire Veteran Affairs Medical Center on 2009-08-12.