Familial Dysbetalipoproteinemia Fredrickson Type III hyperlipoproteinemia
Conditions
Interventions
Bezafibrate retard 400 mg per day
cholesterol
familial dysbetalipoproteinemia (FD)
post-prandial
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - age > 18 years - genetic confirmation of E2 homozygote- or FD dominant genotype in combination with a clinical diagnosis of Familial Dysbetalipoproteinemia - women are postmenopausal - any lipid lowering treatment including lifestyle
Exclusion criteria
Exclusion criteria: - fibrate use - sensitivity/allergy to fibrates - history of galbladder disease - history of rhabdomyolysis - eGFR 3*ULN
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the difference in post fatload non-HDL-C (pre-fatload minus post-fatload) between bezafibrate and placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in the post fat load TC, HDL-C, LDL-C, TG, apoB, CRP, glucose and insulin after an oral fatload between bezafibrate and placebo. Difference in fasting non-HDL-C, TC, HDL-C, LDL-C, TG, apoB, CRP, glucose and insulin between bezafibrate and placebo. Difference in fasting and post fat load adipo(cyto)kines and markers of inflammation between bezafibrate and placebo. Safety of bezafibrate. | — |
Countries
The Netherlands
Outcome results
None listed