The process of atherosclerosis is multifactorial and involves many mechanisms. The majority of published works have identified endothelial dysfunction as the first step in a cascade of events that culminates in plaque formation. Among the various mechanisms that occur following the attack on the vessel wall, it is thought that stem cells in the form of endothelial progenitor cells (EPCs) are the endothelial protection mechanism. Factors identified as cardiovascular risk factors, or rather those conditions which suppose a threat to the vessel wall, should therefore be associated with low levels of EPCs. To date this link has been shown in hypertension, diabetes, hyperlipidaemia, and smoking. Furthermore, the lack of wall protection in situations of low levels of EPCs is clearly a biomarker of cardiovascular morbidity and mortality. On the other hand, the correction of a risk factor allows recuperation of EPCs and is therefore showing itself to be a promising tool for measuring therapeutic efficacy. The tools for correcting EPC levels are not clearly defined. The effect of statins on levels of EPC has been shown, and the low levels of EPCs in diabetes seem to be susceptible to treatment with statins. The role of glucagon-like peptide (GLP-1) is slowly being elucidated but the actual mechanism of its potential endothelial protection is unknown, and its effect on EPCs has not been studied. Liraglutide, a long-acting GLP-1 analogue, could also be an interesting option for long-term vessel wall protection, but to date its ability to correct cardiovascular biomarkers such as EPCs has not been studied.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Liraglutide 1.8 mg/day + metformin \>1500mg/day. Liraglutide will be administered once daily by subcutaneous injection, either in the abdomen, thigh or upper arm. Patients will continue on metformin therapy as they were prescribed before enrolment.
Glimepiride 4 mg/day + metformin \>1500 mg/day. Tablets should be swallowed whole with some liquid before or during a substantial breakfast or, if none is taken, shortly before or during the first main meal. Patients will continue on metformin therapy as they were prescribed before enrolment.
Hospital Clínico San Carlos
Madrid, Madrid, Spain
assess the effect of treatment with liraglutide compared to glimepiride, as add-on to metformin, for one year on circulating levels of EPCs in patients with type 2 diabetes poorly controlled.
Time frame: 1 year
assess the efficacy of liraglutide compared to glimepiride, as add-on to metformin, with regards to other surrogate biomarkers of cardiovascular risk: IMT, Central BP, CD40L, hsCRP, Lp-PLA2, BNP.
Time frame: 1 year
Relationship between EPC levels and all these biomarkers in patients treated with liraglutide compared to those treated with glimepiride.
Time frame: 1 year
Safety parameters of glycaemic control: HbA1c, FPG
Time frame: 1 year
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