A Phase 1 interventional study of Dapagliflozin 10mg and Placebo in Reperfusion Injury and Vascular Complications, sponsored by Medical University of Vienna. Status unknown at 1 site in Austria. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-16.
Sponsored by Medical University of Vienna · Phase 1, Interventional, and Basic science
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.
The aim is to test the effect of dapagliflozin or placebo on ACh-induced vasodilatation of the forearm resistance vasculature as assessed by FBF measurement before and 10 min after a 20 min forearm ischemia as well as after a 14 day treatment period. The area under the dose-effect curve (AUC) of different ACh doses will be calculated and compared between treatment groups (dapagliflozin vs. placebo) and different time points (pre-ischemia vs. post-ischemia). FBF measurements will be made in response to increasing intra-arterial doses of ACh (25, 50, 100 nmol/min) to assess endothelial function or GTN (4, 8, 16 nmol/min) to test vascular smooth muscle vasodilator function.
278 studies on the registry are indexed under Reperfusion Injury; 41 are open to participants now.
This study's planned enrollment of 32 is below the median of 60 across 221 interventional studies indexed under Reperfusion Injury.
Browse Reperfusion Injury studies →Medical University of Vienna is the lead sponsor of 1,105 studies on the registry; 182 are open to participants now.
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14 day orally treatment with dapagliflozin
Drug: Dapagliflozin 10mg
14 day orally treatment with dapagliflozin - placebo
Drug: Placebo
Daily orally administration of 10mg dapagliflozin
Also known as: Forxiga 10mg Tabletten
Daily orally administration of 10mg dapagliflozin-placebo
Also known as: Placebo tablets
Acetylcholine - Area under the curve forearm blood flow measurement
effect of dapagliflozin after a two weeks period of regular intake on forearm blood flow (FBF) reactivity in response to the vasodilators acetylcholine (ACh; endothelium-dependent agonist) or nitroglycerin (GTN; endothelium-independent vasodilator)
Time frame: 14 days
Acetylcholine - Area under the curve forearm blood flow measurement
acute effect of dapagliflozin on forearm blood flow (FBF) reactivity in response to the vasodilators acetylcholine (ACh; endothelium-dependent agonist) or nitroglycerin (GTN; endothelium-independent vasodilator) 10 min before (baseline) and after 20 min forearm ischemia, respectively.
Time frame: 30 min
Plan to share: No
Start is estimated for Feb 2022; primary completion for Feb 2023, 11 months later.
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This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dapagliflozin
Medical University of Vienna →