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NCT00857194 · ClinicalTrials.gov registry record
Cardiovascular Disease Study
A clinical trial of Spinal Cord Injury, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- 170
- Enrollment target
- 2
- Study locations
NCT00857194 is a study of Spinal Cord Injury that has completed, run by VA Office of Research and Development. The registered enrollment target is 170 participants, above the 85-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (100% higher). The trial reports 2 study locations across 2 states.
The verdict
NCT00857194, a study of Spinal Cord Injury, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- 170 participants
- Enrollment target
- 2
- Study locations
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 Studied
Interventions
- PROCEDURE 2 hour Oral Glucose Tolerance Test
- PROCEDURE Fat Meal Test
Study Locations (2)
New Jersey
- Kessler Institute for Rehabilitation - West Orange
New York
- James J. Peters VA Medical Center, Bronx, NY - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2007-03-01 |
| Est. Completion | 2017-06-21 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00857194
The ClinicalTrials.gov registry entry for NCT00857194 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 170 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 85-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (100% higher). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Spinal Cord Injury appearing as the primary indexed condition, and to 2 interventions - of which 2 hour Oral Glucose Tolerance Test is the first listed.
NCT00857194 reports 2 study locations spanning 2 distinct geographic areas - top geographies include New Jersey, New York.
Frequently Asked Questions
What is clinical trial NCT00857194 about?
NCT00857194 is a clinical study titled "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 lipop...
What is the current status of trial NCT00857194?
This trial is currently completed. The enrollment target is 170 participants. The study started on 2007-03-01. Estimated completion is 2017-06-21.
What conditions does trial NCT00857194 study?
This clinical trial studies the following conditions: Spinal Cord Injury.
What interventions are being tested in trial NCT00857194?
The interventions under investigation include: 2 hour Oral Glucose Tolerance Test (PROCEDURE), Fat Meal Test (PROCEDURE).
Who is sponsoring clinical trial NCT00857194?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00857194 being conducted?
This trial has 2 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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