Metformin Therapy in Non-diabetic AAA Patients

• Status: Enrolling by invitation
• Trial end date: 2022-11-15
• Target enrollment: 0
• Participant gender: All

Summary

A prospective randomized, double blind, placebo-controlled, safety and efficacy study of metformin as add-on therapy in abdominal aortic aneurysm (AAA)

OBJECTIVES Primary Objective

• To demonstrate treatment efficacy of metformin in AAA in comparison to placebo or active comparator, as measured by growth of the AAA maximum diameter at 12 months Secondary Objectives

• To asses inflammatory cytokines and parameters of neutrophil activation in AAA in response to metformin treatment by glucose

• insulin

• Interleukin-6

• markers of neutrophil activation (MPO, elastase, NGAL)

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Vienna
• Collaborators: Merck Gesellschaft mbH, Zimbagasse 5, 1147 Vienna, Austria; Merck Serono GmbH, Germany
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Infrarenal AAA of 3-4.9 cm maximum diameter

Exclusion Criteria:

• premenopausal female patients with a pregnancy possibility

• patients with diabetes

• indication for surgical AAA repair

• contraindications for metformin, i.e. severly reduced kidney function (eGFR <30 ml/min), liver dysfunction, pancreatitis, alcohol abusus, malnutrition and decompensated heart failure