Status:
UNKNOWN
Trial to Investigate the Effect of Dapagliflozin on Ischemia Reperfusion Induced Endothelial Dysfunction
Lead Sponsor:
Medical University of Vienna
Conditions:
Reperfusion Injury
Vascular Complications
Eligibility:
MALE
18-40 years
Phase:
PHASE1
Brief Summary
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 b...
Detailed Description
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 is...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05217654
Start Date
February 18 2022
End Date
August 1 2023
Last Update
February 16 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical University of Vienna
Vienna, Austria, 1090