Diabetes Mellitus, Type 1 Clinical Trial
Official title:
The Effects of Empagliflozin on Functional and Structural Arterial Wall Characteristics
Introduction: Diabetes mellitus is characterized by impaired arterial function and high
incidence of cardiovascular events. Metformin and most recent antidiabetic groups of drugs,
SGLT2 inhibitors, were in previous studies shown to reduce cardiovascular events. Until now,
direct effect of empagliflozin on arterial function and its comparison to metformin was not
studied yet.
Aim: The aim of the present study is to explore and compare potential direct effects of
empagliflozin and metformin on arterial functional and structural arterial wall
characteristics in patients with type 1 diabetes mellitus.
Methods: Patients with type 1 diabetes mellitus are randomized into four groups: 1)
empagliflozin (25 mg daily), 2) metformin (2000 mg daily), 3) combination (empagliflozin 25
mg daily and metformin 2000 mg daily) and 4) control (placebo). At inclusion and after 12
weeks treatment, arterial function is assessed: endothelial function (brachial artery
flow-mediated dilation (FMD), reactive hyperemia index (RHI)) and arterial stiffness (carotid
pulse wave velocity (PWV), carotid-femoral PWV (cfPWV) and common carotid artery stiffness
(β-stiffness)).
Status | Recruiting |
Enrollment | 120 |
Est. completion date | January 30, 2019 |
Est. primary completion date | December 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 65 Years |
Eligibility |
Inclusion Criteria: - diabetes mellitus type 1 Exclusion Criteria: - diagnosed advanced heart, kidney or liver failure - benign prostatic hyperplasia - prostatic carcinoma - frequent urinary tract infections - non-type 1 diabetes mellitus |
Country | Name | City | State |
---|---|---|---|
Slovenia | University Medical Centre Ljubljana | Ljubljana |
Lead Sponsor | Collaborator |
---|---|
University Medical Centre Ljubljana |
Slovenia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Arterial function | Endothelial function and arterial stiffness will be measured. | the change of arterial function from baseline to 12 weeks of treatment | |
Secondary | Glycemic control | HbA1c will be measured. | the change of HbA1c from baseline to 12 weeks of treatment |
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