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Completed

NCT Number: NCT00857194

Cardiovascular Disease Study

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.

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Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kessler Institute for Rehabilitation, West Orange, New Jersey, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2 hour Oral Glucose Tolerance Test

Procedure

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

Fat Meal Test

Procedure

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Kessler Foundation

Registry information

Official study title

Risk Factors for Coronary Heart Disease in Spinal Cord Injury: Conventional and Emerging

Important dates

Study start
2007
Primary completion
2017
Study completion
2017
First posted
Mar 6, 2009
Registry last updated
Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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