The objectives of this study are to gain new insights on [1] the cause of a higher clopidogrel resistance in DMII patients[2] the increased production of tissue factor in monocytes in DMII patients
ID
Source
Brief title
Condition
- Platelet disorders
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Part 1 (study on platelets)
[1] Is it possible to identify clopidogrel resistant patients by aggregation
studies?
[2] Is it possible to explain this resistance by a difference in one of the
components in the P2Y12 signalling cascade?
[3] Why does insulin resistance leads to differences in P2Y12 signalling?
Part 2 (study on monocytes)
[1] Do monocytes of DMII patients have a normal inhibiton of tissue factor
production by insulin?
[2] What is the cause of insulin resistance in DMII monocytes?
[3] Is the P2X7 receptor a possible target for interference of tissue factor
production?
Secondary outcome
N/A
Background summary
Patients with diabetes have a absolute or relative defect in insulin
functioning or secretion. They have a higher risk of developing cardiovasculair
diseases compared to healthy individuals. Besides changes in the vessel wall
these patients appear to have hyperactive platelets and an increased activitity
of the coagulation cascade. The platelets and monocytes (the source of tissue
factor, the protein responsible for the start of coagulation) become activated
after an in healthy persons not activating stimulus and can cause pathological
vessel occlusions. Also, the platelets of type II diabetes (DMII) patients are
more resistant against the aggregation inhibiting activity of clopidogrel than
their healthy counterparts. This so-called clopidogrel resistance is associated
with a higher chance of atherothrombosis.
Study objective
The objectives of this study are to gain new insights on
[1] the cause of a higher clopidogrel resistance in DMII patients
[2] the increased production of tissue factor in monocytes in DMII patients
Study design
Observational study
Study burden and risks
Blood (60 ml) is withdrawn from participating subjects only once. Several
experiments can be done with this blood. Besides the fact that subjects can't
have breakfast before the punction, the load and risks for participants are
minimal.
Heidelberglaan 100
3584 CX Utrecht
Nederland
Heidelberglaan 100
3584 CX Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
[1] matched controls
[2] DMII patients taking insulin
[3] DMII patients taking insulin and clopidogrel
[4] DMII patients taking oral bloodglucose lowering drugs (biguanides or sulfonylurea derivatives)
[5] DMII patients taking oral bloodglucose lowering drugs (biguanides or sulfonylurea derivatives) and clopidogrel
Exclusion criteria
Pregnancy
Use of anti-epileptic drugs
Use of acetyl salicylic acid or other non-steroidal anti-inflammatory drugs
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL19880.041.07 |