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Cardiovascular Disease Study

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00857194
Enrollment
170
Registered
2009-03-06
Start date
2007-03-01
Completion date
2017-06-21
Last updated
2017-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury

Keywords

Coronary Heart Disease, spinal cord injury, risk factor, postprandial lipemia

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.

Interventions

PROCEDURE2 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.

PROCEDUREFat 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

Kessler Foundation
CollaboratorOTHER
VA Office of Research and Development
Lead SponsorFED

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
coronary heart disease risk factors1 time, at time of testingRisk factors associated with coronary heart disease as follows: * Fasting Lipid Panel * Oral Glucose Tolerance Test * Blood Pressure * Body Anthropometrics * Family History

Secondary

MeasureTime frameDescription
postprandial lipemic response to a high-fat mealbaseline, 2, 4, and 6 hrs post high fat mealBlood draws following ingestion of high fat meal at 2, 4, and 6 hours to determine lipids.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026