Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Immune Profile and Complications Risk in Type 2 Diabetes
The aim of this study is to investigate the relation between individual differences in
pattern recognition molecules (PRM's) in the innate immune system and the prevalence and
development of vascular complications in patients with type 2 diabetes.
This is based on the hypothesis that pattern recognition molecules (PRM's) in the innate
immune system contributes to a chronic low grade inflammation in diabetic patients.
Variation in PRM's - at the genome, proteome as well as the functional level - are therefore
associated with the degree of chronic low grade inflammation, and probably also with the
prevalence of vascular complications.
Aim: The primary aims of the project are:
1. By use of advanced magnetic resonance imaging to characterize the prevalence of
atherosclerosis in the carotid arteries in patients with newly diagnosed type 2
diabetes.
2. To investigate if individual differences in the innate immune system contributes to the
prevalence and development of cardiovascular disease in patients with type 2 diabetes.
3. To prospectively observe the cardiovascular morbidity and mortality in a cohort of
patients with type 2 diabetes seen in the light of the obtained baseline
characteristics.
Background: Type 2 diabetes is a very common disease in the western world. Patients with
type 2 diabetes are at risk of a number of complications, including macroangiopathy which
involves an accelerated atherosclerosis, that causes most of the increased mortality and
morbidity in type 2 diabetics. Mounting evidence suggests that development of vascular
complications is associated to a chronic low grad inflammation in type 2 diabetes.
Individual differences in the innate immune system might contribute to this chronic low
grade inflammation as it has become apparent that in some situations - as after tissue
ischemia or in diabetes - a change in the body's own cell glycosylations occurs, which leads
to increased affinity of PRM's. This study will focus primarily on two families of PRM's:
Collectins and Toll-like receptors.
Methods: The study consists of a prospective observational cohort study of 100 newly
diagnosed type 2 diabetic patients with continuous 2-year clinical follow-up and a
register-based follow-up of morbidity and mortality study after 5 and 10 years. Furthermore
100 healthy control subjects will be included. Baseline data will represent a independent
cross-sectional study of the relationship between the innate immune system, glycemic control
and the presence of atherosclerosis in the carotid arteries in newly diagnosed type 2
diabetic patients.
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