Cardiovascular Disease Study

Completed

• Conditions: Spinal Cord Injury
• Interventions: Procedure: 2 hour Oral Glucose Tolerance Test; Procedure: Fat Meal Test

• Registration Number: NCT00857194
• Lead Sponsor: VA Office of Research and Development

Brief 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), 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-01
• Study First Submitted: 2009-03-05
• Study First Submitted QC: 2009-03-05
• Study First Posted: 2009-03-06
• Status Verified: 2017-06
• Primary Completion: 2017-06-21
• Study Completion: 2017-06-21
• Last Update Submitted: 2017-06-28
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	Fat Meal Test	Chronic, stable spinal cord injury
Group 2	2 hour Oral Glucose Tolerance Test	Chronic, stable spinal cord injury

Primary Outcome Measures

Name	Time	Method
coronary heart disease risk factors	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

Secondary Outcome Measures

Name	Time	Method
postprandial lipemic response to a high-fat meal	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.

Trial Locations

Locations (2)

Kessler Institute for Rehabilitation; 🇺🇸 West Orange, New Jersey, United States

James J. Peters VA Medical Center, Bronx, NY; 🇺🇸 The Bronx, New York, United States