Overview

Trial to Investigate the Effect of Dapagliflozin on Ischemia Reperfusion Induced Endothelial Dysfunction

Status:
Not yet recruiting
Trial end date:
2023-08-01
Target enrollment:
0
Participant gender:
Male
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 by FBF measurement before and 10 minutes after 20 minutes of forearm ischemia.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Medical University of Vienna
Treatments:
Dapagliflozin
Criteria
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