Cardiovascular Disease Study

NCT00857194 | Completed

• 1 other identifier: B4162C-5
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 2

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.

Conditions

Spinal Cord Injury

Keywords

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

Outcome Measures

Primary Outcomes (1)

• coronary heart disease risk factors

  Risk factors associated with coronary heart disease as follows: * Fasting Lipid Panel * Oral Glucose Tolerance Test * Blood Pressure * Body Anthropometrics * Family History

  1 time, at time of testing

Secondary Outcomes (1)

• postprandial lipemic response to a high-fat meal

  baseline, 2, 4, and 6 hrs post high fat meal

Study Arms (1)

Group 2

Chronic, stable spinal cord injury

Procedure: 2 hour Oral Glucose Tolerance Test; Procedure: Fat Meal Test

Interventions

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.

Also known as: 2-hr OGTT

Group 2

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.

Group 2

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from hospital clinics, through advertisements, and referral from primary care physicians.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Kessler Foundation: collaborator

Study Sites (2)

Kessler Institute for Rehabilitation

West Orange, New Jersey, 07052, United States

Location

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and plasma

MeSH Terms

Conditions

Spinal Cord Injuries; Coronary Disease

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Officials

• William Bauman, MD

  James J. Peters Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2009
• First Posted: March 6, 2009
• Study Start: March 1, 2007
• Primary Completion: June 21, 2017
• Study Completion: June 21, 2017
• Last Updated: July 2, 2017

Record last verified: 2017-06

Locations

US (2)