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

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT03131232
• Lead Sponsor: RWTH Aachen University

Brief Summary

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

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 Timeline

• Study Start: 2015-12-10
• Status Verified: 2017-04
• Study First Submitted: 2017-04-13
• Study First Submitted QC: 2017-04-24
• Last Update Submitted: 2017-04-24
• Study First Posted: 2017-04-27
• Last Update Posted: 2017-04-27
• Primary Completion: 2017-08-01
• Study Completion: 2017-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The effect of empagliflozine on glucose metabolism	6 month	NT-pro BNP in pg/ml

Secondary Outcome Measures

Name	Time	Method
Lipid measurements	6 month	LDL-C in mg/dl HDL-C in mg/dl TG (triglyceride) in mg/dl
Frequency of urinary and urogenital infections	6 month	Urinary infection as reported by the patient CRP (Creactive protein) in mg/dl
detection differential regulation of endogenous and exogenous metabolites in addition to circulating proteins by empagliflozin.	6 month	perform metabolomic and proteomic profiling of serum samples
- echocardiographic parameters (if collected) with determination of the systolic and diastolic left ventricular function	6 month	LV-EF (left ventricular ejection fraction) in % LV (left ventricular) global strain