Trial to Investigate the Effect of Dapagliflozin on Ischemia Reperfusion Induced Endothelial Dysfunction
- Sponsor
- Medical University of Vienna
- Study ID
- NCT05217654
- Phase
- PHASE1
- Status
- Unknown
Conditions
- Reperfusion Injury
- Vascular Complications
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - 40 Years
- Healthy Volunteers
- Accepted
Interventions
- Dapagliflozin 10mg — DRUGDaily orally administration of 10mg dapagliflozin
- Placebo — DRUGDaily orally administration of 10mg dapagliflozin-placebo
Study Details
The aim of the study is to investigate the effect of dapagliflozin or placebo on acetylcholine (Ach)- or nitroglycerin (GTN)-induced vasodilation of the forearm resistance vasculature, as determined by FBF measurement before and 10 minutes after 20 minutes of forearm ischemia.
Key Dates
- Start date
- Feb 18, 2022
- Status verified
- Feb 2022
- Primary completion
- Feb 1, 2023
- Completion
- Aug 1, 2023
Study Design
- Enrollment
- 32 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- BASIC_SCIENCE
Arms
- Active Comparator: Dapagliflozin14 day orally treatment with dapagliflozin
- Placebo Comparator: Dapagliflozin-placebo14 day orally treatment with dapagliflozin - placebo
Primary Outcome Measure
Acetylcholine - Area under the curve forearm blood flow measurement [ Time Frame: 14 days ]
Central Contacts
- Martin Lutnik, M.D.+43 1 40400
- Michael Wolzt, M.D.+43 1 40400
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