Cardiovascular Disease Study
|ClinicalTrials.gov Identifier: NCT00857194|
Recruitment Status : Completed
First Posted : March 6, 2009
Last Update Posted : July 2, 2017
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 or disease||Intervention/treatment|
|Spinal Cord Injury||Procedure: 2 hour Oral Glucose Tolerance Test Procedure: Fat Meal Test|
|Study Type :||Observational|
|Actual Enrollment :||170 participants|
|Official Title:||Risk Factors for Coronary Heart Disease in Spinal Cord Injury: Conventional and Emerging|
|Actual Study Start Date :||March 1, 2007|
|Primary Completion Date :||June 21, 2017|
|Study Completion Date :||June 21, 2017|
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 OGTTProcedure: 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.
- 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
- postprandial lipemic response to a high-fat meal [ Time Frame: baseline, 2, 4, and 6 hrs post high fat meal ]Blood draws following ingestion of high fat meal at 2, 4, and 6 hours to determine lipids.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00857194
|United States, New Jersey|
|Kessler Institute for Rehabilitation|
|West Orange, New Jersey, United States, 07052|
|United States, New York|
|James J. Peters VA Medical Center, Bronx, NY|
|The Bronx, New York, United States, 10468|
|Principal Investigator:||William Bauman, MD||VA Office of Research and Development|