Reperfusion Injury Clinical Trial
Official title:
A Randomized, Double - Blind, Placebo - Controlled Trial to Investigate the Effect of Dapagliflozin on Ischemia Reperfusion Induced Endothelial Dysfunction of the Forearm Vasculature in Healthy Male Subjects
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.
Status | Recruiting |
Enrollment | 32 |
Est. completion date | August 1, 2023 |
Est. primary completion date | February 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - Healthy male subjects; 18 - 40 years of age - Body mass index between 18 and 27 kg/m2 - Written informed consent - Normal findings in medical history - Non-smoking Exclusion Criteria: - Regular intake of any medication including OTC drugs and herbals within 2 weeks before IMP administration - History of occlusive vascular diseases - History of vascular anomalies - History of coagulation disorders - History of diabetes mellitus (Type 1&2) or pre-diabetes (i.e. HbA1c = 5,7 %) - History of kidney disease - History of ketoacidosis - Impaired liver function (AST, ALT, gGT, bilirubin >3 x ULN) - Impaired renal function (serum creatinine > 1.3 mg/dl) - Any other relevant deviation from the normal range in clinical chemistry, haematology or urine analysis - HIV-1/2-Ab, HbsAg or HCV-Ab positive serology - Systolic blood pressure above 145 mmHg, diastolic blood pressure above 95 mmHg - Known allergy against any test agent under study and/or lactose intolerance - Regular daily consumption of more than on litre of xanthine-containing beverages or more than 40g alcohol - Participation in another clinical trial during the preceding 3 weeks |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University of Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
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* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | 14 days | |
Primary | 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. | 30 min |
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