To evaluate the difference in the post fat load non HDL after an oral fatload between bezafibrate and placebo in patients with FD using standard lipid-lowering therapy
ID
Source
Brief title
Condition
- Lipid metabolism disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the difference in post fatload non-HDL-C
(pre-fatload minus post-fatload) between bezafibrate and placebo.
Secondary outcome
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.
Background summary
Patients with familial dysbetalipoproteinemia (FD) have increased
triglycerides, non-high-density lipoprotein cholesterol (non-HDL-C), beta-VLDL,
premature atherosclerosis and cardiovascular disease. They also have a delayed
post-prandial triglyceride and chylomicron remnant (CM) clearance.
Post-prandial hypertriglyceridemia is associated with increased vascular risk.
Although combination therapy with statin and fibrate is recommended in the
treatment of patients with FD, the evidence is old and based on small numbers
of patients. Furthermore no information is available about the postprandial
effects of adding a fibrate to standard lipid lowering therapy in FD patients.
Study objective
To evaluate the difference in the post fat load non HDL after an oral fatload
between bezafibrate and placebo in patients with FD using standard
lipid-lowering therapy
Study design
Randomised, double blind, cross-over trial. It consist of 2 treatment periods
in which patients receive Bezafibrate and placebo in a randomised order.
Between treatment periods is a 2 week cross-over period. Before treatment
period 1 and at the end of the 2 treatment periods patients visit the hospital
for an oral fatload. Before an after the fatload blood samples are collected
through an intravenous catheter. Patients have to stay untill 6 hours after the
fatload and receive a meal at the end. Before the visits to the hospital people
have to fast for at least 8 hours (meaning that they cannot eat or drink
anything, except water). The study lasts 18 weeks in total.
Intervention
Bezafibrate retard 400 mg per day
Study burden and risks
Risk: low but known and unknown side effects of Bezafibrate can occur. Minimal
risk concerning venapunctions are pain, hematoma or infection of injection
site.
Burden: patients are asked to keep a stable diet an alcohol consumption. They
have to visit the UMCU 4 times in total. Before all the visits patients have to
fast for 8 hours. Three of the visits include ingestion of an oral fatload
(unsweetened cream). Patients might not like the taste of the cream. The 3
visits can last up to 7 hours. The screenings visit lasts 60 minutes.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-000524-26-NL |
| CCMO | NL52026.041.15 |