Can metformin prevent endothelial ischemia and reperfusion injury?

Phase 1

• Conditions: ischemia and reperfusion injuryendothelial dysfunction; MedDRA version: 14.1Level: PTClassification code 10063837Term: Reperfusion injurySystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-005343-27-NL
• Lead Sponsor: Radboud University Nijmegen Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-16
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

-Age 30-50 years
-Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Smoking
-Hypertension (in supine position: systole > 140 mmgHg, diastole > 90 mmHg)
-Hyperlipidaemia (fasting total cholesterol > 5.5 mmol/L or random > 6.5 mmol/L)
-Diabetes Mellitus (fasting glucose > 7.0 mmol/L or random glucose > 11.0 mmol/L)
-History of any cardiovascular disease
-Concomitant chronic use of medication
-Renal dysfunction (MDRD < 60 ml/min)
-Professional athletes

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Metformin-FMD trial<br>To study the effect of oral pretreatment with metformin (500 mg three times a day for 3 days) on flow mediated dilation of the brachial artery after 20 minutes of forearm ischemia and 20 minutes reperfusion in healthy volunteers. <br><br>Control study:<br>To study whether caffeine, a non-selective competitive antagonist of adenosine receptors, attenuates the protective effect of metformin on flow mediated dilation after 20 minutes of ischemia and 20 minutes reperfusion in healthy volunteers.;Secondary Objective: not applicable;Primary end point(s): Difference in flow mediated dilation before and after 20 minutes of ischemia. ;Timepoint(s) of evaluation of this end point: as outlined in protocol

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable