An observational study in Hypertriglyceridemia and Insulin Resistance, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-14.
Sponsored by University of Alabama at Birmingham · Observational
Fenofibrate is one of the best options for treating hypertriglyceridemia. In the majority of patients, fenofibrate lowers triglycerides (TG) by 24-55% and improves HDL- and LDL-cholesterol. However, the response to fenofibrate is highly variable and currently there are no screening tests to identify poor responders. Genetic and environmental factors may explain the high variability in response. Although exploratory in nature, this study is of clinical and public health importance because prediction of drug response among those with hypertriglyceridemia is clinically challenging and fenofibrate prescription costs are large ($90 to $130/patient/month); targeting the responsive patients at the outset will help improve treatment outcomes at a lower cost. If successful, the investigators will propose to conduct a large, randomized trial on the effect of pre-prescription genotyping on fenofibrate response.
1,960 studies on the registry are indexed under Insulin Resistance; 305 are open to participants now.
This study's enrollment of 39 is below the median of 80 across 339 observational studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Women who are seen in the UAB Diabetes and Endocrine Clinic or Cardiology Clinic
Exclusion Criteria:
Drug: Fenofibrate
Participants will give a baseline blood sample and begin the 4 week course of fenofibrate. Patients will be given a 33-day dose of 145 mg of fenofibrate to be taken by mouth once a day. All doses of fenofibrate will be purchased in one batch, prepared at the pharmacy under supervision. A study nurse will collect each patient's 33-day dose of fenofibrate from the pharmacy and dispense to the study participants in the clinics. Patients will be given instructions on how to take the medication and given a 24-hr phone number to call in case of questions or need for additional care. Each patient will receive a phone call at least 2 times during the course of the trial to monitor the progress. Our co-investigators, who are also physicians will be available in case a study participant needs additional care. If not available, study participants will be able to reach the cardiologist or endocrinologist on call through an additional phone number we will provide.
Also known as: Brand Name: TRICOR, NDC# 00074-6123-90
Change in fasting triglyceride concentrations
Time frame: 4 weeks
Changes in lipids and markers of insulin resistance
Time frame: 4 weeks
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham