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

February 15, 2022 updated by: Michael Wolzt, Prof. MD, Medical University of Vienna

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • Medical University of Vienna
        • Contact:
        • Principal Investigator:
          • Michael Wolzt, Prof. Dr.
        • Sub-Investigator:
          • Martin Lutnik, Dr.
        • Sub-Investigator:
          • Stefan Weisshaar, DDr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dapagliflozin
14 day orally treatment with dapagliflozin
Drug: Dapagliflozin 10mg
Daily orally administration of 10mg dapagliflozin
Other Names:
  • Forxiga 10mg Tabletten
Placebo Comparator: Dapagliflozin-placebo
14 day orally treatment with dapagliflozin - placebo
Drug: Placebo
Daily orally administration of 10mg dapagliflozin-placebo
Other Names:
  • Placebo tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acetylcholine - Area under the curve forearm blood flow measurement
Time Frame: 14 days
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
Acetylcholine - Area under the curve forearm blood flow measurement
Time Frame: 30 min
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 18, 2022

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

January 5, 2022

First Submitted That Met QC Criteria

January 20, 2022

First Posted (Actual)

February 1, 2022

Study Record Updates

Last Update Posted (Actual)

February 16, 2022

Last Update Submitted That Met QC Criteria

February 15, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FBF-SGLT2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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