The Effect of Empagliflozin on Glucose Metabolism, Weight, Blood Pressure and Cardiac Function (NT-proBNP) Should be Investigated

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Aim of This Study is to Investigate the Protective Effect of Empagliflozin on the Cardiovascular System in Diabetes Mellitus Patients

Conditions
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Diabetes Mellitus, Type 2

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetes mellitus II Patients with whom an empagliflozine treatment is to be initiated from a clinical indication Exclusion Criteria: Inability to consent to the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of empagliflozine on glucose metabolism | HbA1c in % | 6 month | 
| The effect of empagliflozine on glucose metabolism | Body weight in kg | 6 month | 
| The effect of empagliflozine on glucose metabolism | BMI in kg/m² | 6 month | 
| The effect of empagliflozine on glucose metabolism | blood pressure in mmHg | 6 month | 
| The effect of empagliflozine on glucose metabolism | NT-pro BNP in pg/ml | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of urinary and urogenital infections | Urinary infection as reported by the patient CRP (Creactive protein) in mg/dl | 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 | 6 month | 
| Lipid measurements | LDL-C in mg/dl HDL-C in mg/dl TG (triglyceride) in mg/dl | 6 month | 
| - echocardiographic parameters (if collected) with determination of the systolic and diastolic left ventricular function | LV-EF (left ventricular ejection fraction) in % LV (left ventricular) global strain | 6 month |