Cardiovascular Disease Study

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Procedure: 2 hour Oral Glucose Tolerance Test; Procedure: Fat Meal Test

• Study Type: Observational
• Enrollment (Actual): 170

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • Kessler Institute for Rehabilitation
  • New York
    • The Bronx, New York, United States, 10468
      • James J. Peters VA Medical Center, Bronx, NY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from hospital clinics, through advertisements, and referral from primary care physicians.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 time, at time of testing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline, 2, 4, and 6 hrs post high fat meal

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Kessler Foundation
• Investigators: Principal Investigator: William Bauman, MD, James J. Peters Veterans Affairs Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2007
• Primary Completion (ACTUAL): June 21, 2017
• Study Completion (ACTUAL): June 21, 2017

Study Registration Dates

• First Submitted: March 5, 2009
• First Submitted That Met QC Criteria: March 5, 2009
• First Posted (ESTIMATE): March 6, 2009

Study Record Updates

• Last Update Posted (ACTUAL): July 2, 2017
• Last Update Submitted That Met QC Criteria: June 28, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: spinal cord injury; Coronary Heart Disease; risk factor; postprandial lipemia
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: B4162C-5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No