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Metformin Therapy in Non-diabetic AAA Patients

NCT03507413 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2024-03-28

No results posted yet for this study

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)

Conditions

  • Abdominal Aortic Aneurysm

Interventions

DRUG

Metformin Glucophage 500mg (IR) tablets M90

oral metformin Glucophage treatment 500 mg daily (2-0-2) for 1 year

DRUG

Placebo Oral Tablet

Placebo Oral Tablet M90 treatment twice daily (2-0-2) for 1 year

Sponsors & Collaborators

  • Merck Serono GmbH, Germany

    collaborator INDUSTRY

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Christoph Neumayer, MD · Medical University of Vienna

  • Wolf-Hans Eilenberg, MD, PhD · Medical University of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-26
Primary Completion
2024-05-01
Completion
2024-05-01

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03507413 on ClinicalTrials.gov