NCT01610401

The Metformin-FMD Trial

Can Metformin Prevent Endothelial Ischemia and Reperfusion Injury? The Metformin-FMD Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 30 Years – 50 Years
• Healthy volunteers: Accepted

Summary

In acute myocardial infarction early restoration of coronary blood flow is the most effective strategy to limit infarct-size. Paradoxically, reperfusion itself also aggravates myocardial injury and contributes to final infarct size, a process termed 'reperfusion injury'. Ischemia and reperfusion (IR)-induced endothelial dysfunction seems to play a pivotal role in this process, resulting in vasoconstriction and reduced blood flow to the already ischemic tissue. Recently, it has been shown that the glucose-lowering drug metformin is able to limit IR-injury in murine models of myocardial infarction, probably by increased formation of the endogenous nucleoside adenosine. In the current research proposal, the investigators aim to translate this finding to the human in vivo situation, using flow-mediated dilation (FMD) of the brachial artery as a well-validated model of (endothelial) IR-injury.

Conditions

• Ischemia Reperfusion Injury
• Endothelial Function

Interventions

Type	Name	Description
DRUG	Metformin	metformin 500 mg three times a day, for 3 days
DRUG	Pretreatment with metformin in combination of infusion of caffeine.	Pretreatment with metformin 500 mg three times a day for 3 days, in combination with pretreatment with caffeine (4 mg/kg intravenously over 10 minutes) prior to FMD measurement
DRUG	No pretreatment with metformin in combination with infusion of caffeine	No pretreatment with metformin in combination with pretreatment with caffeine (4 mg/kg intravenously over 10 minutes).

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2012-06-04
• Last updated: 2013-05-20

Locations

1 site across 1 country: Netherlands