Assessment of vascular form and function in Diabetes Mellitus by Non Invasive Vascular tools

Cardiovascular disease (CVD) is the leading cause of mortality in patients with
diabetes. Thus, early risk stratification, recognition of CVD and treatment is
essential. Diabetic patients in the LUMC are screened for CVD as part of an
integrated screening program incorporated in the routine patient care. In this
manner we strive to improve management of diabetes, identify new mechanisms of
pathology and to evaluate diagnostic screening and treatment possibilities.

Non invasive vascular measurements are essential for the complete understanding
of the vascular system under physiologic and pathologic conditions.
Importantly, noninvasive vascular tools as markers for atherosclerosis may help
in risk stratification and in implementation of tailored therapy for the
individual patient with diabetes mellitus (DM). However, the clinical value of
these tools has not been extensively validated in the diabetic population.
Therefore it is necessary to evaluate these tests for identification of
diabetic patients at risk for CVD. It is important to test the prognostic
capacity of non invasive vascular measurements on top of clinical risk scores
before they can be implemented on large scale in clinical practice.

Non invasive vascular measurements which will be evaluated for their use in
diabetic patinets in this study, include the intima media thickness of the
carotid arteries (CIMT), pulse wave velocity (PWV), flow mediated dilation
(FMD), orthogonal polarization spectral (OPS).
CIMT is a surrogate marker for atherosclerosis.
PWV is a validated estimator of vascular stiffness.
FMD is often applied as a non invsaive measurement to assess endothelial
function.
OPS imaging enables visualization of the capillaries and therefore enables
assessment of capillary density and structure.

To evaluate the correlation between the findings from the explained non
invasive vascular tools (CIMT, PWV, FMD and OPS imaging) with prevalent CVD in
diabetic individuals.

To evaluate the potential of non invasive vascular tools for identification of
diabetic patients at risk for CVD.

To investigate the prognostic value of non invasive vascular tools in
prediction of cardiovascular events.

To evaluate whether the implementation of non invasive vascular tools will
provide the clinician with additional information on top of the clinical risk
scores in risk stratification for CVD in DM.

To assess the features of microvascular disease in DM. To analyse the influence
of DM on capillary density and structure.

To evaluate the correlation between the observations made none invasively by
OPS imaging in the labial capillaries with organic microvascular disease (i.e.
myocardial ischemia, retinopathy) in DM.

To investigate the factors which influence the prevalence and extent of
microvascular disease in DM.

The study is designed as an observational study in diabetic patients who
undergo screening for CVD as part of clinical care.

Associated risk and burden:
There are no risks or side effects associated with the non invasive vasular
tools which will be applied in the study.

Benefit:
Better understanding of the pathophysiology of (cardio-)vascular disease and
microvascular disease in patients with diabetes mellitus.
Improvement of risk straitification, more accurate identification of diebatic
patients at risk for cardiovascular disease and implementation of tailored
therapy.