Cardiovascular Disease Study

NCT00857194 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 170

Last updated 2017-07-02

No results posted yet for this study

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.

Conditions

  • Spinal Cord Injury

Interventions

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.

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.

Sponsors & Collaborators

  • Kessler Foundation

    collaborator OTHER
  • VA Office of Research and Development

    lead FED

Principal Investigators

  • William Bauman, MD · James J. Peters Veterans Affairs Medical Center

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-01
Primary Completion
2017-06-21
Completion
2017-06-21

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00857194 on ClinicalTrials.gov