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

Medical University of Vienna

Status and phase: Unknown; Phase 1

Conditions: Vascular Complications; Reperfusion Injury

Treatments: Drug: Dapagliflozin 10mg; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05217654

FBF-SGLT2

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 32 estimated patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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32 participants in 2 patient groups, including a placebo group

Dapagliflozin

Active Comparator group

Description:

14 day orally treatment with dapagliflozin

Treatment:

Drug: Dapagliflozin 10mg

Dapagliflozin-placebo

Placebo Comparator group

Description:

14 day orally treatment with dapagliflozin - placebo

Treatment:

Drug: Placebo