The primary objective is to compare the amount, type and localisation of AGEs of the arterial wall of PAD, AAA and PAD+AAA in patients with and without diabetes mellitus.The secondary objectives are to explore the association between AGEs content of…
ID
Source
Brief title
Condition
- Vascular therapeutic procedures
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is to compare the amount, type and localisation of AGEs
of the arterial wall of PAD, AAA and PAD+AAA between patients with and without
diabetes mellitus.
Secondary outcome
The secondary objectives are to explore the association between AGEs content of
the arterial wall of PAD, AAA and PAD+AAA patients and (1) serum, urine and
skin AGEs, (2) in vivo and in vitro mechanical properties of the arterial wall
and (3) serum, urine and tissue markers of inflammation and oxidative stress.
Background summary
Peripheral artery disease (PAD) and abdominal aortic aneurysms (AAA) are often
simultaneously found in patients although these conditions have different
pathophysiology. PAD and AAA share smoking as major risk factor. However,
diabetes mellitus is a risk factor for occlusive vascular disease and
protective effect in dilating disease. Accumulation of advanced glycation end
products (AGEs) in the arterial wall could possibly explain the different
effects of diabetes mellitus on these diseases. AGEs are sugar modified
proteins which are formed under influence of oxidative and glycemic stress.
AGEs have the potential to form cross-links and to induce inflammatory and
oxidative stress responses after binding to the receptor for AGE. Increased
accumulation of AGEs is associated with elevated risk of cardiovascular
morbidity and mortality in several diseases.
Study objective
The primary objective is to compare the amount, type and localisation of AGEs
of the arterial wall of PAD, AAA and PAD+AAA in patients with and without
diabetes mellitus.
The secondary objectives are to explore the association between AGEs content of
the arterial wall of PAD, AAA and AAA+PAD patients and (1) serum, urine and
skin AGEs, (2) in vivo and in vitro mechanical properties of the arterial wall
and (3) serum, urine and tissue markers of inflammation and oxidative stress.
Study design
Multicenter observational cross-sectional study design.
Study burden and risks
Patients do not have benefit in this study. Patients have to fill in a
questionnaire about cardiovascular risk factors, one additional visit is
necessary to the hospital for noninvasive vascular measurements (3 hours) and
60 ml blood will be drawn by venipuncture. For the vascular measurements and
the blood tests, the patients will be asked to fast at least 8 hours before the
tests. On the day before the additional hospital visit, 24h urine will be
collected. During surgery, a noninvasive echo graphic measurement will be
performed and waste material of the arterial wall will be collected. The
measurements during surgery prolong surgery time with a maximum of 10 minutes.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
Age above 18 years old.
Written informed consent for study participation.
Proven PAD or AAA
PAD: patients planned for a bypass surgery or endarterectomy of the lower arteries, and/or:
AAA: patients planned for an open repair of the aneurysm.
Exclusion criteria
Patients not able or willing to sign informed consent.
rheumatoid arthritis, systemic lupus erythematosus, Giant Cell Arteritis, retroperitoneal fibrosis, Takayasu arteritis or any other systemic inflammatory disorder.
Patients with Ehlers-Danlos syndrom or Marfan syndrom
Patients with signs of an inflammatory or mycotic aneurysm (on computed tomographic angiography).
Design
Recruitment
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 |
|---|---|
| CCMO | NL45660.042.14 |
| OMON | NL-OMON29072 |