Body Composition Assessment in Spinal Cord Injury

NCT ID: NCT00957762

Last Updated: 2009-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2012-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus Body Composition Tetraplegia Paraplegia Spinal Cord Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Body composition

Intervention Type OTHER

Day 1 testing will incorporate underwater weighing, Bod Pod, DXA, BIA and anthropometrics. Day 2 will include RMR, MRI, and testing at GCRC

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Spinal Cord Injury Percentage body fat

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hunter Holmes Mcguire Veteran Affairs Medical Center

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hunter Holmes McGuire VA

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David R Gater, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hunter Holmes McGuire VAMC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hunter Holmes McGuire Spinal Cord Injury Research Lab

Richmond, Virginia, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Joshua Miller, MS

Role: CONTACT

804-675-6200

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Joshua Miller, MS

Role: primary

804-675-6200

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HM12090

Identifier Type: -

Identifier Source: secondary_id

B6232I

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Feeding Regulation in SCI
NCT05406739 COMPLETED NA
Cardiovascular Disease Study
NCT00857194 COMPLETED