Clinical trial NCT01023750: Predictors of Response to Fenofibrate
Official title: Pretreatment Genotyping at APOA5 and GCKR Loci and Response to Fenofibrate Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertriglyceridemia
Insulin Resistance
Keywords: hypertriglyceridemia
Triglycerides
HDL
Insulin resistance
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Tufts University
name: University of Minnesota
First posted: 2009-12-02
Enrollment: 39
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who are seen in the UAB Diabetes and Endocrine Clinic or Cardiology Clinic

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 19 years old or over dyslipidemic patients designated to receive fenofibrate by their attending physician.
* All patients will be seen at the UAB Diabetes and Endocrine Clinic or Cardiology Clinic.
* Women who are unable to have children because of surgery or other medical reason or are using an effective form of birth control before the study begins and agree to continue to use an effective form of birth control for 6 months after taking the study drug.

Exclusion Criteria:

* Under 19 and/or not a Dyslipidemic patient or dyslipidemic but with a medical condition (e.g., liver or kidney disease) that warrants contraindication of fenofibrate.
* Women who are pregnant, nursing and women who, unless they are unable to have children because of surgery or other medical reason, have not been using an effective form of birth control before the study begins and/or are unwilling to use an effective form of birth control for 6 months after taking the study drug will be excluded from the study.

Primary outcomes:
measure: Change in fasting triglyceride concentrations
timeFrame: 4 weeks
Secondary outcomes:
measure: Changes in lipids and markers of insulin resistance
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Kirklin Clinic
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Edmond K Kabagambe, DVM, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.