Can metformin prevent endothelial ischemia and reperfusion injury?

Can metformin prevent endothelial ischemia and reperfusion injury? The Metformin-FMD trial. - The Metformin-FMD trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005343-27-NL

Enrollment

Registered

2012-01-16

Start date

2012-01-27

Completion date

Unknown

Last updated

2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ischemia and reperfusion injury endothelial dysfunction MedDRA version: 14.1 Level: PT Classification code 10063837 Term: Reperfusion injury System Organ Class: 10047065 - Vascular disorders

Interventions

Trade Name: Metformin Product Name: Metformin Product Code: 100904 Pharmaceutical Form: Capsule INN or Proposed INN: METFORMIN HYDROCHLORIDE CAS Number: 1115-70-4 Current Sponsor code: metformin Other

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Metformin-FMD trial 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. Control study: 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	—

Measure

Time frame

Main Objective: Metformin-FMD trial 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. Control study: 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

Measure	Time frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Netherlands

Contacts

Public ContactDept. of Pharmacology-Toxicology

Radboud University University Medical Centre

G.Rongen@pharmtox.umcn.nl+31243613691

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026