To explore the inflammatory changes of a PCSK-9 inhibitor compared with placebo on postprandial lipemia and postprandial leukocyte activation, oxidative stress and endothelial function in men with type 2 diabetes mellitus.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Lipid metabolism disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Postprandial leukocyte inflammation markers
Secondary outcome
Postprandial lipemia, oxidative stress parameters and vascular function.
Background summary
Diabetes mellitus type 2 (T2DM) is characterized by a 2-fold increased risk in
cardiovascular mortality. Several risk factors are involved. The presence of
small dense LDL, low HDL-C but also postprandial hyperlipidemia with increased
concentrations of chylomicron and VLDL remnants leading tot postprandial
inflammation and impaired vascular function, have been implicated. Current
therapies like statins and fibrates have only minor effects on these risk
factors. Since remnant particles are also cleared by the LDL-R, upregulation of
this system may lead to improved postprandial lipemia and inflammation and
consequently to decreased cardiovascular risk.
Study objective
To explore the inflammatory changes of a PCSK-9 inhibitor compared with placebo
on postprandial lipemia and postprandial leukocyte activation, oxidative stress
and endothelial function in men with type 2 diabetes mellitus.
Study design
Randomized, double blind pilot study.
Study burden and risks
The use of a pcsk9 inhibitor every two weeks (Q2W) has been established to be a
safe and effective treatment for hypercholesterolemia. Volunteers will be
hospitalized on 2 different days (day 1, day 43) for approximately nine hours
each day and receive an oral fat load. The volunteers* general practitioner
will be informed on their participation. A total of 222ml (111ml for each
postprandial test) of blood will be drawn. Volunteers will be allowed to drink
only water during the tests. Volunteers receive 250 euros for full
participation. Furthermore, volunteers will be informed and given advice if
there are additional cardiovascular risk factors or any other conditions
Kleiweg 500
Rotterdam 3045 PM
NL
Kleiweg 500
Rotterdam 3045 PM
NL
Listed location countries
Age
Inclusion criteria
- Age of 18 years or older
- Male
- Fasting triglycerides levels between 1.8 mmol/L and 7.0 mmol/L
- Diabetes mellitus type 2 on intensive insulin treatment (three times short acting and one daily long acting) (unchanges 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 regiments or dose)
Exclusion criteria
- Current smoking
- Impaired renalfunction (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 antibodies
- HIV-infection
- Uncontrolled hypothyroidism
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
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-003253-15-NL |
| CCMO | NL58836.101.16 |
| OMON | NL-OMON22535 |