Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Effect of Liraglutide on Vascular Inflammation in Type-2 Diabetes: A Randomized, Placebo-controlled, Double-blind, Parallel Clinical PET/CT Trial The Liraflame Trial
The objective of this study is to evaluate the mechanism behind the anti-atherogenic effects
of liraglutide.
In a randomized, placebo-controlled, double-blind, parallel trial we will included 100
patients with type 2 diabetes. Patients will be randomized 1:1 to an active treatment period
of 26 weeks or placebo for 26 weeks.
The primary endpoint is change from baseline to week 26 in vascular inflammation, assessed by
Flour Deoxy Glucose (FDG)-Positron Emission Tomography/Computed Tomography (PET/CT)
Despite multifactorial treatment patients with type 2 diabetes are still at high risk of
cardiovascular disease. The clinical LEADER trial demonstrated a reduction in cardiovascular
events in patients with type 2 diabetes treated with the GLP-1 receptor agonist liraglutide
and there are a number of studies indicating that liraglutide has a positive effect on the
vascular phenotype. Several of the animal or ex vivo studies suggest an anti-inflammatory
mechanism behind this effect. However, no in vivo human studies have been undertaken to test
this hypothesis and it would be of significance to determine the precise mechanism since
atherosclerosis has large prognostic impact in patients with type 2 diabetes.
The objective of this study is to evaluate the mechanism behind the anti-atherogenic effects
of liraglutide.
In a randomized, placebo-controlled, double-blind, parallel trial we will included 100
patients with type 2 diabetes. Patients will be randomized 1:1 to an active treatment period
of 26 weeks or placebo for 26 weeks.
The primary endpoint is change from baseline to week 26 in vascular inflammation, assessed by
Flour Deoxy Glucose (FDG)-Positron Emission Tomography/Computed Tomography (PET/CT).
FDG-PET/CT is currently the only clinically available technique for specific in vivo
evaluation of vascular inflammation and for quantification of the effects of medical
intervention on plaque inflammation. FDG-PET of arteries has been proven very reproducible
and therefore has high power to show a treatment effect in a smaller group of patients.
A number of complementary methods exist that assess different steps in the atherogenesis like
endothelial function (e.g. endo-PAT, glycocalyx measurement), artery wall thickening (e.g.
carotid intima media thickness), or coronary atherosclerosis (e.g. coronary artery calcium
score). For comparison these other methods will be included as secondary endpoints as they
are generally more accessible and less expensive.
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