Fenofibrate Treatment in SCI

• Status: Completed
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Cardiovascular disease-related morbidity in persons with spinal cord injury (SCI) occurs earlier in life, at a greater prevalence than that of the general population, and is the primary cause of death after the first year of injury. During the chronic phase of SCI, a characteristic dyslipidemia emerges, which is characterized by low serum high density lipoprotein cholesterol (HDL-C) concentrations, with values often qualifying to be an independent risk factor for coronary artery disease, and elevations in serum triglycerides (TG). Serum low density lipoprotein cholesterol concentrations in those with SCI are usually similar to those of the general population. The current proposal in persons with SCI aims to determine the safety and efficacy of short-term fenofibrate treatment, an anti-lipid medication whose primary action lowers serum TG and raises serum HDL-C levels.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Fenofibrate

Criteria

Inclusion Criteria:

• Male or female, age 21 to 69;

• Chronic (e.g., duration of injury at least 6 months), stable SCI (regardless of level of neurological lesion);

• American Spinal Injury Association Impairment Scale (AIS) designation of A, B or C; and

• TG concentration 135 mg/dl (paraplegia) or 115 mg/dl (tetraplegia).

Exclusion Criteria:

• Acute illness or infection;

• Reduced kidney function (by glomerular filtration rate (GFR <60 ml/min) or liver function tests (LFTs 2.5 standard deviations above the upper limit of normal);

• Current pharmacological treatment with: HMG-CoA reductase inhibitors (statins), or any other hypolipidemic agent; anti-coagulant therapy; cyclosporine; or any other medications known to effect the TG concentration (i.e., -blockers, thiazides or estrogen);

• Hypersensitivity to fenofibrate;

• Existing diagnosis of atherosclerosis, congestive heart failure, or recent history of myocardial infarction (i.e., 12 months);

• Pregnancy or women who may become pregnant during the course of the study, or those who are nursing;

• Diminished mental capacity; and

• Inability or unwillingness of subject to provide informed consent.

• Existing diagnosis of diabetes mellitus, or the results from screening blood tests indicate that diabetes mellitus is present (and perhaps undiagnosed); laboratory thresholds for exclusion will be as follows: HbA1C 6.5% and fasting plasma glucose is >126 mg/dl.