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

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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus, Type 2

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 Type: Observational
• Enrollment (Actual): 46

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

If possible, all patients of the Department MK1 Uniklinik Aachen who are treated with empagliflozine

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Investigators: Study Director: Dirk DM Müller Wieland, Scientific Director, Coordination Center for Clinical Study

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 10, 2015
• Primary Completion (ANTICIPATED): August 1, 2017
• Study Completion (ANTICIPATED): December 31, 2017

Study Registration Dates

• First Submitted: April 13, 2017
• First Submitted That Met QC Criteria: April 24, 2017
• First Posted (ACTUAL): April 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 27, 2017
• Last Update Submitted That Met QC Criteria: April 24, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 15-152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No