This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Cardiovascular Disease Study

This study has been completed.
Sponsor:
Collaborator:
Kessler Foundation
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00857194
First received: March 5, 2009
Last updated: June 28, 2017
Last verified: June 2017
March 5, 2009
June 28, 2017
March 1, 2007
June 21, 2017   (Final data collection date for primary outcome measure)
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
coronary heart disease risk factors [ Time Frame: 1 time, at time of testing ]
Complete list of historical versions of study NCT00857194 on ClinicalTrials.gov Archive Site
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.
postprandial lipemic response to a high-fat meal [ Time Frame: baseline, 2, 4, and 6 hrs post high fat meal ]
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Case-Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
serum and plasma
Non-Probability Sample
Subjects will be recruited from hospital clinics, through advertisements, and referral from primary care physicians.
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 Name: 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.
Group 2
Chronic, stable spinal cord injury
Interventions:
  • Procedure: 2 hour Oral Glucose Tolerance Test
  • Procedure: Fat Meal Test
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
170
June 21, 2017
June 21, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
45 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00857194
B4162C-5
No
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
Plan to Share IPD: Undecided
VA Office of Research and Development
VA Office of Research and Development
Kessler Foundation
Principal Investigator: William Bauman, MD VA Office of Research and Development
VA Office of Research and Development
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP