Diabetes MellitusNCT00957762
Body Composition Assessment in Spinal Cord Injury
An observational study of Diabetes Mellitus and Body Composition, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Body Composition, Tetraplegia
- What is being tested?
- Body composition
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with a spinal cord injury of C5-L2 motor complete (AIS A\&B only).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Hunter Holmes McGuire Spinal Cord Injury Research Lab
Richmond, Virginia, 23249
Joshua Miller, MS, 804-675-6200, Joshua.Miller@va.gov
About this study
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).
Read the 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.
- Conditions
- Diabetes Mellitus, Body Composition, Tetraplegia, Paraplegia, Spinal Cord Injury
- Being tested
- Body composition
- Keywords
- Body Composition, Glucose Tolerance, Insulin Sensitivity, Metabolic Syndrome
- Medical subject headings
- Diabetes Mellitus, Quadriplegia, Paraplegia, Spinal Cord Injuries, Insulin Resistance, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body compositionOther
Also called Spinal Cord Injury, Percentage body fat
Day 1 testing will incorporate underwater weighing, Bod Pod, DXA, BIA and anthropometrics. Day 2 will include RMR, MRI, and testing at GCRC
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Body composition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (3)
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)
Measured: 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.
Measured: 3 years
To cross-validate the derived regression equations against the gold standard 4-compartment model in an independent group of persons with SCI.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionSep 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical Center
- Sponsor type
- US federal agency
- Investigators
- David R Gater, MD, PhD, Principal investigator, Hunter Holmes McGuire VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957762
- Sponsor's protocol ID
- B6232I
- Other IDs
- HM12090
- Status last verified
- Aug 2009
- First submitted
- 5 Aug 2009
- Last updated
- 12 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Composition Assessment in Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT00957762
- Acronym / sponsor ID
- B6232I
- Conditions
- Diabetes Mellitus, Body Composition, Tetraplegia, Paraplegia, Spinal Cord Injury
- Keywords
- Body Composition, Glucose Tolerance, Insulin Sensitivity, Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical CenterUS federal agency
- Study start
- Aug 2009
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 12 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Body Composition | – | Other: Body composition120 subjects will help create the regression models. The remaining 50 subjects will be recruited to determine if the equations work for the population. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with a spinal cord injury of C5-L2 motor complete (AIS A\&B only).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body compositionAlso: Spinal Cord Injury, Percentage body fatDay 1 testing will incorporate underwater weighing, Bod Pod, DXA, BIA and anthropometrics. Day 2 will include RMR, MRI, and testing at GCRC | Other | Body Composition |
Primary outcome
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
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David R Gater, MD, PhD principal investigator
Hunter Holmes McGuire VAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Body Composition, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joshua Miller, MS (804-675-6200, Joshua.Miller@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2009.