Spinal Cord InjuryNCT00857194
Cardiovascular Disease Study
An observational study of Spinal Cord Injury, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
Coronary heart disease (CHD) is a leading cause of death in the spinal cord injured (SCI) population, occurring at younger ages than in the able-bodied population. Conventional risk factors for CHD include high concentrations of low-density lipoprotein (LDL), low concentrations of high-density lipoprotein (HDL)… Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- 2 hour Oral Glucose Tolerance Test and Fat Meal Test
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 170 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2007to 21 Jun 2017
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be recruited from hospital clinics, through advertisements, and referral from primary care physicians.
Who may be able to join
- Male 45-75 years old with at least 5 years of SCI
- Female 45-50 years old with at least 10 years of SCI
- Female 50-75 years old with at least 5 years of SCI
Who cannot join
- Acute medical illness
- Pregnant females
- Chronic debilitating disease (i.e., heart disease, pulmonary disease, etc.)
- Atrial fibrillation
- History of percutaneous coronary angiography with stent placement
Trial locations and contacts
2 sites in 1 country.
United States2 sites
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, 10468
Kessler Institute for Rehabilitation
West Orange, New Jersey, 07052
About this study
Official title: Risk Factors for Coronary Heart Disease in Spinal Cord Injury: Conventional and Emerging
Coronary heart disease (CHD) is a leading cause of death in the spinal cord injured (SCI) population, occurring at younger ages than in the able-bodied population. Conventional risk factors for CHD include high concentrations of low-density lipoprotein (LDL), low concentrations of high-density lipoprotein (HDL), diabetes mellitus (DM), smoking history, and family history. Other factors that may influence progression of CHD include C-reactive protein (an inflammatory marker), and fibrinogen (a pro-coagulant marker). Individuals with SCI with longer duration and greater completeness of injury are more likely to have significantly worse carbohydrate tolerance compared to other neurological deficit subgroups. Muscle atrophy after SCI is associated with increased insulin resistance. Prolonged inactivity has been shown to be associated with hyperinsulinemia and impaired glucose tolerance. Body composition changes after SCI to indicate significantly more total body fat mass and percent fat and less lean mass compared to able-bodied individuals. Carotid intima-media thickness is correlated with atherosclerosis progression and abdominal adiposity. Individuals with abdominal adiposity are at a higher risk for CHD, DM, hypertension, insulin resistance, and dyslipidemia. Abdominal adiposity and insulin resistance are contributors to postprandial lipemia, which may be a more sensitive indicator of CHD risk and progression.
The purpose of this study is to determine the prevalence of conventional risk factors by assessing the 10-year risk for CHD, and identify emerging risk factors for CHD in the spinal cord injured population. Subjects will have the option to participate in a high fat meal test to determine postprandial lipemic responses. Knowledge of this information may be able to detect and prevent future cardiovascular events related to CHD.
- Conditions
- Spinal Cord Injury
- Being tested
- 2 hour Oral Glucose Tolerance Test, Fat Meal Test
- Keywords
- Coronary Heart Disease, spinal cord injury, risk factor, postprandial lipemia
- Medical subject headings
- Spinal Cord Injuries, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 hour Oral Glucose Tolerance TestProcedure or surgery
Also called 2-hr OGTT
Fasting baseline blood samples will be drawn for analysis of insulin and glucose. A 75-gram glucose solution will be administered and subjects remain sedentary for 2 hours. After 2 hours, blood is drawn to analyze post-load insulin and glucose levels.
Fat Meal TestProcedure or surgery
A fasting blood draw is performed for analysis of lipids, insulin, and glucose. Subjects ingest a high fat meal (milkshake made from heavy whipping cream and premium ice cream) within 15 minutes. Postprandial blood draws at 2, 4, and 6 hours are made for analysis of lipids, insulin, and glucose.
| Study group | Role | What they receive |
|---|---|---|
| Group 2 | Chronic, stable spinal cord injury Receives: Procedure: 2 hour Oral Glucose Tolerance Test; Procedure: Fat Meal Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
coronary heart disease risk factors
Risk factors associated with coronary heart disease as follows:
- Fasting Lipid Panel
- Oral Glucose Tolerance Test
- Blood Pressure
- Body Anthropometrics
- Family History
Measured: 1 time, at time of testing
Secondary outcomes (1)
postprandial lipemic response to a high-fat meal
Blood draws following ingestion of high fat meal at 2, 4, and 6 hours to determine lipids.
Measured: baseline, 2, 4, and 6 hrs post high fat meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2009 (estimated)
- Study start1 Mar 2007
- Primary completion21 Jun 2017
- Study completion21 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Kessler Foundation
- Responsible party
- Sponsor
- Investigators
- William Bauman, MD, Principal investigator, James J. Peters Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00857194
- Sponsor's protocol ID
- B4162C-5
- Status last verified
- Jun 2017
- First submitted
- 5 Mar 2009
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Coronary Heart Disease in Spinal Cord Injury: Conventional and Emerging
- ClinicalTrials.gov ID
- NCT00857194
- Acronym / sponsor ID
- B4162C-5
- Conditions
- Spinal Cord Injury
- Keywords
- Coronary Heart Disease, spinal cord injury, risk factor, postprandial lipemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Kessler Foundation
- Study start
- 1 Mar 2007 (actual)
- Primary completion
- 21 Jun 2017 (actual)
- Study completion
- 21 Jun 2017 (actual)
- First posted
- 6 Mar 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.
Coronary heart disease (CHD) is a leading cause of death in the spinal cord injured (SCI) population, occurring at younger ages than in the able-bodied population. Conventional risk factors for CHD include high concentrations of low-density lipoprotein (LDL), low concentrations of high-density lipoprotein (HDL), diabetes mellitus (DM), smoking history, and family history. Other factors that may influence progression of CHD include C-reactive protein (an inflammatory marker), and fibrinogen (a pro-coagulant marker). Individuals with SCI with longer duration and greater completeness of injury are more likely to have significantly worse carbohydrate tolerance compared to other neurological deficit subgroups. Muscle atrophy after SCI is associated with increased insulin resistance. Prolonged inactivity has been shown to be associated with hyperinsulinemia and impaired glucose tolerance. Body composition changes after SCI to indicate significantly more total body fat mass and percent fat and less lean mass compared to able-bodied individuals. Carotid intima-media thickness is correlated with atherosclerosis progression and abdominal adiposity. Individuals with abdominal adiposity are at a higher risk for CHD, DM, hypertension, insulin resistance, and dyslipidemia. Abdominal adiposity and insulin resistance are contributors to postprandial lipemia, which may be a more sensitive indicator of CHD risk and progression.
The purpose of this study is to determine the prevalence of conventional risk factors by assessing the 10-year risk for CHD, and identify emerging risk factors for CHD in the spinal cord injured population. Subjects will have the option to participate in a high fat meal test to determine postprandial lipemic responses. Knowledge of this information may be able to detect and prevent future cardiovascular events related to CHD.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 2 | – | Procedure: 2 hour Oral Glucose Tolerance Test, Procedure: Fat Meal TestChronic, stable spinal cord injury |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from hospital clinics, through advertisements, and referral from primary care physicians.
Key inclusion criteria (3 listed)
- Male 45-75 years old with at least 5 years of SCI
- Female 45-50 years old with at least 10 years of SCI
- Female 50-75 years old with at least 5 years of SCI
Key exclusion criteria (5 listed)
- Acute medical illness
- Pregnant females
- Chronic debilitating disease (i.e., heart disease, pulmonary disease, etc.)
- Atrial fibrillation
- History of percutaneous coronary angiography with stent placement
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 |
|---|---|---|
| 2 hour Oral Glucose Tolerance TestAlso: 2-hr OGTTFasting baseline blood samples will be drawn for analysis of insulin and glucose. A 75-gram glucose solution will be administered and subjects remain sedentary for 2 hours. After 2 hours, blood is drawn to analyze post-load insulin and glucose levels. | Procedure or surgery | Group 2 |
| Fat Meal TestA fasting blood draw is performed for analysis of lipids, insulin, and glucose. Subjects ingest a high fat meal (milkshake made from heavy whipping cream and premium ice cream) within 15 minutes. Postprandial blood draws at 2, 4, and 6 hours are made for analysis of lipids, insulin, and glucose. | Procedure or surgery | Group 2 |
Primary outcome
coronary heart disease risk factors
Time frame: 1 time, at time of testing
Risk factors associated with coronary heart disease as follows: * Fasting Lipid Panel * Oral Glucose Tolerance Test * Blood Pressure * Body Anthropometrics * Family History
1 secondary outcome
postprandial lipemic response to a high-fat meal
Time frame: baseline, 2, 4, and 6 hrs post high fat meal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Individual participant dataSharing planned: Undecided
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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.
William Bauman, MD principal investigator
James J. Peters Veterans Affairs Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury, run by VA Office of Research and Development at 2 sites 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
coronary heart disease risk factors (time frame: 1 time, at time of testing). 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 2 Jul 2017.