In summary, the registry should provide novel insight into potential mechanisms of cardiovascular risk reduction in patients treated with Empagliflozin with an indication of intensified glucose lowering therapy based on their HbA1c level.
Patients with diabetes exhibit an increased risk for the development of cardiovascular disease with a significantly impaired prognosis compared to patients without diabetes. Recent data from the EMPA-REG Outcome Trial suggest that treatment with the SGLT-2 inhibitor Empagliflozin reduces cardiovascular events, cardiovascular mortality as well as hospitalization for heart failure in patients with type 2 diabetes and pre-existing cardiovascular disease. Empagliflozin leads to reduction of blood glucose by an increased glucose excretion reduces blood pressure and weight. Still, it remains unclear how empagliflozin led to this pronounced reduction of cardiovascular mortality the EMPA-REG OUTCOME trial. Thus, our registry will analyse various biochemical as well as clinical markers in patients with type 2 diabetes and newly initiated treatment with empagliflozin. and an indication for intensification of glucose lowering therapy with empagliflozin. Patients with an indication for an intensified glucose-lowering therapy (HbA1c \> 7,5%) will receive 10 mg empagliflozin and we will perform biochemical analyses of blood samples including insulin, glucagon as well as metabolites at baseline as well as after 1 and 6 months. In addition we will assess echocardiographical data.
Study Type
OBSERVATIONAL
Enrollment
46
The effect of empagliflozine on glucose metabolism
HbA1c in %
Time frame: 6 month
The effect of empagliflozine on glucose metabolism
Body weight in kg
Time frame: 6 month
The effect of empagliflozine on glucose metabolism
BMI in kg/m²
Time frame: 6 month
The effect of empagliflozine on glucose metabolism
blood pressure in mmHg
Time frame: 6 month
The effect of empagliflozine on glucose metabolism
NT-pro BNP in pg/ml
Time frame: 6 month
Frequency of urinary and urogenital infections
Urinary infection as reported by the patient CRP (Creactive protein) in mg/dl
Time frame: 6 month
detection differential regulation of endogenous and exogenous metabolites in addition to circulating proteins by empagliflozin.
perform metabolomic and proteomic profiling of serum samples
Time frame: 6 month
Lipid measurements
LDL-C in mg/dl HDL-C in mg/dl TG (triglyceride) in mg/dl
Time frame: 6 month
- echocardiographic parameters (if collected) with determination of the systolic and diastolic left ventricular function
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LV-EF (left ventricular ejection fraction) in % LV (left ventricular) global strain
Time frame: 6 month