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| Name | Class |
|---|---|
| Tufts University | OTHER |
| University of Minnesota | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fenofibrate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fenofibrate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fasting triglyceride concentrations | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in lipids and markers of insulin resistance | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Women who are seen in the UAB Diabetes and Endocrine Clinic or Cardiology Clinic
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| Name | Affiliation | Role |
|---|---|---|
| Edmond K Kabagambe, DVM, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Kirklin Clinic | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36873949 | Derived | Lai CQ, Parnell LD, Lee YC, Zeng H, Smith CE, McKeown NM, Arnett DK, Ordovas JM. The impact of alcoholic drinks and dietary factors on epigenetic markers associated with triglyceride levels. Front Genet. 2023 Feb 15;14:1117778. doi: 10.3389/fgene.2023.1117778. eCollection 2023. | |
| 32930325 | Derived | Lai CQ, Parnell LD, Smith CE, Guo T, Sayols-Baixeras S, Aslibekyan S, Tiwari HK, Irvin MR, Bender C, Fei D, Hidalgo B, Hopkins PN, Absher DM, Province MA, Elosua R, Arnett DK, Ordovas JM. Carbohydrate and fat intake associated with risk of metabolic diseases through epigenetics of CPT1A. Am J Clin Nutr. 2020 Nov 11;112(5):1200-1211. doi: 10.1093/ajcn/nqaa233. |
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| ID | Term |
|---|---|
| D015228 | Hypertriglyceridemia |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D011345 | Fenofibrate |
| ID | Term |
|---|---|
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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|
|
| D009750 |
| Nutritional and Metabolic Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D007659 | Ketones |