Treatment 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…
ID
Bron
Verkorte titel
Aandoening
Diabetes Mellitus Type 2 (T2DM), postprandial lipemia
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Primary endpoint is effect of alirocumab on postprandial leukocyte activation markers (CD11b, CD66b and CD35).
Achtergrond van het onderzoek
Few 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.
Doel van het onderzoek
Treatment 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
Onderzoeksopzet
0 and 12 weeks
Onderzoeksproduct en/of interventie
9 weeks treatment with either biweekly alirocumab 150 mg or bikweeekly matching placebo.
Before and after treatment oral fat loading test (OFLT).
Publiek
Benjamin Burggraaf
Kleiweg 500
Rotterdam 3045 PM
The Netherlands
b.burggraaf@franciscus.nl
Wetenschappelijk
Benjamin Burggraaf
Kleiweg 500
Rotterdam 3045 PM
The Netherlands
b.burggraaf@franciscus.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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)
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6521 |
| NTR-old | NTR6709 |
| CCMO | NL58836.101.16 |
| OMON | NL-OMON43374 |