Clinical Trial Details
| Trial ID: | L3857 |
| Source ID: | NCT03132181 |
| Associated Drug: | Empagliflozin |
| Title: | Empagliflozin as a Modulator of Systemic Vascular Resistance and Cardiac Output in Patients With Type 2 Diabetes |
| Acronym: | EMPA |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus Type 2 (T2DM) |
| Interventions: | DRUG: Empagliflozin|OTHER: Placebo |
| Outcome Measures: | Primary: Mode of action, vascular resistance (dyn\*s/cm\^5), 3 months|Mode of action, cardiac output (l/min), 3 months | Secondary: Hemodynamics, Stroke volume (ml/beat), 3 months|Hemodynamics, stroke volume variation (%), 3 months|Energie expenditure, resting energy expenditure (calories/24h), 3 months|Cardio cascular, blood pressure (mmHg), 3 months|Urine, 24 h sodium excretion (mmol/day), 3 months|Body weight, body weight (kg), 3 months|Cardio vascular, heart rate (bpm), 3 months|Blood, NT-proBNP (ng/l), 3 months|Blood, cystatin C(mg/dl), 3 months|Blood, serum levels of Glucose (mg/dl), 3 months|Blood, HbA1c (%), 3 months|Metabolism, total-ketone bodies (mmol/l), 3 months |
| Sponsor/Collaborators: | Sponsor: RWTH Aachen University | Collaborators: Boehringer Ingelheim |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 40 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2017-04-24 |
| Completion Date: | 2019-01-23 |
| Results First Posted: | |
| Last Update Posted: | 2019-02-12 |
| Locations: | Department of Internal Medicine I RWTH Aachen University Hospital, Aachen, NRW, 52074, Germany |
| URL: | https://clinicaltrials.gov/show/NCT03132181 |
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