Cardiovascular Disease Study
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Spinal Cord Injury |
Procedure: 2 hour Oral Glucose Tolerance Test Procedure: Fat Meal Test |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Risk Factors for Coronary Heart Disease in Spinal Cord Injury: Conventional and Emerging |
- coronary heart disease risk factors [ Time Frame: 1 time, at time of testing ] [ Designated as safety issue: No ]
- postprandial lipemic response to a high-fat meal [ Time Frame: baseline, 2, 4, and 6 hrs post high fat meal ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
serum and plasma
| Estimated Enrollment: | 200 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Group 1
Able-bodied Control
|
Procedure: 2 hour Oral Glucose Tolerance Test
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.
Other Name: 2-hr OGTT
Procedure: Fat Meal Test
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.
|
|
Group 2
Chronic, stable spinal cord injury
|
Procedure: 2 hour Oral Glucose Tolerance Test
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.
Other Name: 2-hr OGTT
Procedure: Fat Meal Test
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Subjects will be recruited from hospital clinics, through advertisements, and referral from primary care physicians.
Inclusion Criteria:
- Male or female, age 18 to 70 years
- Chronic (duration at least 6 months), stable SCI (regardless of level of lesion or completeness of injury)
- Able-bodied controls
Exclusion Criteria:
- Acute medical illness
- Pregnant females
- Chronic disease (i.e., heart disease, pulmonary disease, etc.)
- Known diabetes
- Competitive athlete
- Lipid-lowering therapy
Contacts and Locations| United States, New Jersey | |
| Kessler Institute for Rehabilitation | |
| West Orange, New Jersey, United States, 07052 | |
| United States, New York | |
| VA Medical Center, Bronx | |
| Bronx, New York, United States, 10468 | |
| Principal Investigator: | William Bauman, MD | VA Medical Center, Bronx |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00857194 History of Changes |
| Other Study ID Numbers: | B4162C-5 |
| Study First Received: | March 5, 2009 |
| Last Updated: | December 5, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Coronary Heart Disease spinal cord injury risk factor postprandial lipemia Healthy Able-bodied Controls |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Spinal Cord Injuries Arteriosclerosis |
Arterial Occlusive Diseases Vascular Diseases Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 22, 2013