| Trial ID: | L3200 |
| Source ID: | NCT02471963
|
| Associated Drug: |
Empagliflozin
|
| Title: |
Effect of Empagliflozin on Macrovascular and Microvascular Circulation and on Endothelium Function
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus Type 2
|
| Interventions: |
DRUG: Empagliflozin|DRUG: Placebo
|
| Outcome Measures: |
Primary: Effect of empagliflozin after 6 weeks of treatment on macrocirculation, To analyse the effect of empagliflozin after 6 weeks of treatment on macrocirculation as assessed by the pulse wave reflection in the peripheral arterial tree with the composite parameters: central (aortic) systolic pressure, central (aortic) pulse pressure, augmentation pressure, forward wave amplitude, backward wave amplitude and the ratio of forward and backward (pulse wave velocity) compared to placebo., 6 weeks | Secondary: Effect of empagliflozin after 6 weeks of treatment on microcirculation, To analyse the effect of empagliflozin after 6 weeks of treatment on retinal capillary flow (as key measurement of vascular remodeling in the microcirculation) and retinal vascular structural components., 6 weeks|Endothelium Function, To analyse the effect of empagliflozin after 6 weeks of treatment on peripheral endothelial function by measuring endothelium-mediated changes in arterial tone using a reactive hyperemia procedure, 6 weeks|Biomarkers, To analyse the effect of empagliflozin after 6 weeks of treatment on biomarkers for inflammation, metabolic disorders and albuminuria., 6 weeks
|
| Sponsor/Collaborators: |
Sponsor: University of Erlangen-Nürnberg Medical School
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
74
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2014-12
|
| Completion Date: |
2016-06
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| Results First Posted: |
|
| Last Update Posted: |
2018-05-15
|
| Locations: |
University of Erlangen-Nuremberg, Erlangen, Bavaria, 91054, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT02471963
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