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Postprandial effects of alirocumab on lipemia and inflammtion


- candidate number27932
- NTR NumberNTR6709
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-sep-2017
- Secondary IDsNL58836.101.16 TWOR Maasstad Ziekenhuis
- Public TitlePostprandial effects of alirocumab on lipemia and inflammtion
- Scientific TitleMODULATION OF POSTPRANDIAL LIPEMIA, INFLAMMATION, AND VASCULAR FUNCTION BY PCSK9 INHIBITION IN DIABETES
- ACRONYMPLEIADES-pcsk9
- hypothesisTreatment with alirocumab will reduce postprandial hyperlipidemia and thus reduce postprandial leukocyte activation, diminish the generation of postprandial oxidative stress and improve postprandial vascular dysfunction in men with type 2 diabetes mellitus
- Healt Condition(s) or Problem(s) studiedPostprandial lipemia, Diabetes Mellitus Type 2 (DM type II)
- Inclusion criteria Age of 18 years of older;
Male
Diabetes mellitus type 2 on intensive insulin treatment (three times short acting and once daily long acting) (unchanged for > 10 weeks prior to consent)
Stable glucose regulation last 6 months (HbA1c > 6.5% - < 9.0%)
Stable lipid lowering therapy last 2 months (no changes in regiment or dose)
- Exclusion criteria Current smoking
Impaired renal function (MDRD <60 ml/min/1.73 m2)
Recent cardiovascular event (< 6 months) (myocardial infarction, coronary artery bypass grafting, stroke)
Severe hyperglycemic events in the past 6 months (hyperglycemia >20 mmol/l requiring hospital admittance)
Recent or current use of PCSK9 inhibitors
HIV-infection
Uncontrolled hypothyroidism
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2017
- planned closingdate31-okt-2018
- Target number of participants20
- Interventions9 weeks treatment with either biweekly alirocumab 150 mg or bikweeekly matching placebo.
Before and after treatment oral fat loading test (OFLT).
- Primary outcomePrimary endpoint is effect of alirocumab on postprandial leukocyte activation markers (CD11b, CD66b and CD35).
- Secondary outcomeSecondary endponts are the effect of 9 weeks of treatment with alirocumab on postprandial lipemia (apoB48, triglycerides, free fatty acids and b-hydroxybutyrate), oxidative stress (myeloperoxidase) and vascular function (arterial pulse wave velocity and arterial pulse wave analysis).
- Timepoints0 and 12 weeks
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Benjamin Burggraaf
- CONTACT for SCIENTIFIC QUERIES Benjamin Burggraaf
- Sponsor/Initiator Franciscus Gasthuis
- Funding
(Source(s) of Monetary or Material Support)
Regeneron
- Publications
- Brief summaryFew studies have proven to be efficient in reducing cardiovascular risk in diabetes. Recently, treatment of patients at high cardiovascular risk with a pcks9-inhibito has proven to both significantly reduce LDL-cholesterol and cardiovascular risk. We aimed to explore the postprandial effects of alirocumab both on lipids and inflammation in male subjects with type 2 diabetes on intensive insulin treatment.
- Main changes (audit trail)
- RECORD19-sep-2017 - 7-okt-2017


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