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Studie naar het effect van ursodeoxycholzuur (ursochol) en ezetimibe op de uitscheiding van vetten in de ontlasting en op de concentratie van vetten in het bloed


- candidate number28767
- NTR NumberNTR7128
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-apr-2018
- Secondary IDsNL56321.018.16 METC AMC
- Public TitleStudie naar het effect van ursodeoxycholzuur (ursochol) en ezetimibe op de uitscheiding van vetten in de ontlasting en op de concentratie van vetten in het bloed
- Scientific TitleThe effect of ursodeoxycholicacid (UDCA) and ezetimibe on total faecal sterol excretion and plasma lipid levels.
- ACRONYMEXCRETE
- hypothesisWe hypothesize that UDCA on top of ezetimibe leads to an increased cholesterol excretion via the feces by stimulating ABCG5/8 and preventing absorption of cholesterol due to blocking NPC1L1 and therefore promoting elimination of cholesterol from the body.
- Healt Condition(s) or Problem(s) studiedHypercholesterolemia
- Inclusion criteria- Hypercholesterolemia, with LDL plasma levels >2.6 mmol/L
- Body mass index (BMI) ¡İ19 ¡Ü30 kg/m2
- Use of statin therapy (stable dose for 3 months) or no statin therapy at all
- Exclusion criteria- Medical, surgical, laboratory or other conditions, which in the judgment of the Physician Investigator would make the subject unsuitable for enrollment, or potentially interfere with subject participation or completion of the study
- Suffering from an inflammatory bowel disease, e.g. Crohn¡¯s disease or ulcerative colitis.
- Suffering from gall stones or another biliary disease.
- Suffering diabetes mellitus (type I or II).
- Recent history of, or current drug or alcohol abuse
- AST or ALT levels > 2 x ULN
- Unable or unwilling to comply with the protocol requirements or deemed by the investigator to be unfit for the study.
- Presence of contra indications for the use of UDCA and ezetimibe (see SPC)
- Use of lipid lowering drugs such as the following:
o Statins and fibrates unless on a stable dose for at least 3 months prior to screening
o Use of nicotinic acid or derivates of nicotinic acid within 4 weeks prior to screening
o Use of cholestyramine or colestipol
- Use of other drugs such as the following:
o Ciclosporine
o Antacids containing aluminium hydroxide or aluminium oxide
- Likely to leave the study before its completion
- Participation in other intervention studies
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2018
- planned closingdate1-apr-2020
- Target number of participants20
- InterventionsUrsodeoxycholicacid (UDCA) 600mg once daily or placebo

Background therapy: ezetimibe 10mg once daily
- Primary outcomeTotal faecal sterol concentration (faecal total neutral sterol concentration (FNS) + faecal bile acid concentration)
- Secondary outcomeLipid profile/composition: LDL-c, HDL-c, TG, apoB, apoA1.
- TimepointsVisit 1 (Day 0): Screening
Visit 2 (Day 21): Randomization
Visit 3 (Day 35): end of treatment period 1 + start washout period
Visit 4 (Day 56): start treatment period 2
Visit 5 (Day 70): end of treatment period 2 + end of study
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD, PhD student Rens Reeskamp
- CONTACT for SCIENTIFIC QUERIESMD, PhD student Rens Reeskamp
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Amsterdam
- Publications
- Brief summaryIntestinal cholesterol secretion is mediated via the ATP binding cassette (ABC) half transporters G5 and G8 (ABCG5/G8) while cholesterol absorption is mediated by the Niemann-Pick C1 Like (NPC1L1) protein, which is inhibited by ezetimibe. There is growing evidence that hydrophilic bile acids like ursochol (ursodeoxycholic acid, UDCA) promote ABCG5/G8 activity in mice.
The primary objective is to evaluate the effect of UDCA and ezetimibe on cholesterol elimination assessed as total faecal sterol concentration. Secondary objective is to assess the effect of UDCA and ezetimibe on plasma lipid profile/composition.
The current study is an investigator initiated, single-centre, randomized, double blind, placebo-controlled , cross-over, proof of concept study, to explore the translational relevance of UDCA on top of ezetimibe on cholesterol elimination.
- Main changes (audit trail)
- RECORD5-apr-2018 - 15-apr-2018


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