A randomized, double blind, cross-over trial to study the effects of adding bezafibrate to standard lipid lowering therapy on postprandial lipids in patients with Familial Dysbetalipoproteinemia <br>

Phase 4

Completed

• Conditions: Familial Dysbetalipoproteinemia; Fredrickson Type III hyperlipoproteinemia; 10013317

• Registration Number: NL-OMON43954
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

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

- fibrate use
- sensitivity/allergy to fibrates
- history of galbladder disease
- history of rhabdomyolysis
- eGFR <60 ml/min/1.73m2
- Impaired liver function
- CK > 3*ULN

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the difference in post fatload non-HDL-C<br /><br>(pre-fatload minus post-fatload) between bezafibrate and placebo. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Difference in the post fat load TC, HDL-C, LDL-C, TG, apoB, CRP, glucose and<br /><br>insulin after an oral fatload between bezafibrate and placebo.<br /><br><br /><br>Difference in fasting non-HDL-C, TC, HDL-C, LDL-C, TG, apoB, CRP, glucose and<br /><br>insulin between bezafibrate and placebo.<br /><br><br /><br>Difference in fasting and post fat load adipo(cyto)kines and markers of<br /><br>inflammation between bezafibrate and placebo.<br /><br><br /><br>Safety of bezafibrate.</p><br>