Clinical trial NCT03131232: The Effect of Empagliflozin on Glucose Metabolism, Weight, Blood Pressure and Cardiac Function (NT-proBNP) Should be Investigated
Official title: The Aim of This Study is to Investigate the Protective Effect of Empagliflozin on the Cardiovascular System in Diabetes Mellitus Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2017-04-27
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: If possible, all patients of the Department MK1 Uniklinik Aachen who are treated with empagliflozine

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.

Eligibility criteria: 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

Primary outcomes:
measure: The effect of empagliflozine on glucose metabolism
timeFrame: 6 month
measure: The effect of empagliflozine on glucose metabolism
timeFrame: 6 month
measure: The effect of empagliflozine on glucose metabolism
timeFrame: 6 month
measure: The effect of empagliflozine on glucose metabolism
timeFrame: 6 month
measure: The effect of empagliflozine on glucose metabolism
timeFrame: 6 month
Secondary outcomes:
measure: Frequency of urinary and urogenital infections
timeFrame: 6 month
measure: detection differential regulation of endogenous and exogenous metabolites in addition to circulating proteins by empagliflozin.
timeFrame: 6 month
measure: Lipid measurements
timeFrame: 6 month
measure: - echocardiographic parameters (if collected) with determination of the systolic and diastolic left ventricular function
timeFrame: 6 month
Other outcomes:
Locations:
Study officials:
affiliation: Coordination Center for Clinical Study
name: Dirk DM Müller Wieland, Scientific Director
role: STUDY_DIRECTOR
References: