No registrations found.
ID
Source
Brief title
Health condition
Diabetes Mellitus Type 2 (T2DM), postprandial lipemia
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is effect of alirocumab on postprandial leukocyte activation markers (CD11b, CD66b and CD35).
Secondary outcome
Secondary 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).
Background summary
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.
Study objective
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
Study design
0 and 12 weeks
Intervention
9 weeks treatment with either biweekly alirocumab 150 mg or bikweeekly matching placebo.
Before and after treatment oral fat loading test (OFLT).
Benjamin Burggraaf
Kleiweg 500
Rotterdam 3045 PM
The Netherlands
b.burggraaf@franciscus.nl
Benjamin Burggraaf
Kleiweg 500
Rotterdam 3045 PM
The Netherlands
b.burggraaf@franciscus.nl
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
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6521 |
| NTR-old | NTR6709 |
| CCMO | NL58836.101.16 |
| OMON | NL-OMON43374 |