NCT03507413

Brief 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)

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2018

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 25, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

September 26, 2018

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

March 28, 2024

Status Verified

March 1, 2024

Enrollment Period

5.6 years

First QC Date

March 29, 2018

Last Update Submit

March 27, 2024

Conditions

Abdominal Aortic Aneurysm

Keywords

abdominal aortic aneurysmmetforminnon-diabeticplacebo

Outcome Measures

Primary Outcomes (1)

  • AAA growth over 12 months in mm

    AAA maximum diameter in CT scan

    12 months

Secondary Outcomes (6)

  • inflammation markers IL-6

    12 months

  • glucose markers insulin and glucose

    12 months

  • neutrophil markers NGAL

    12 months

  • ineutrophil marker MPO

    12 months

  • neutrophil marker elastase

    12 months

  • +1 more secondary outcomes

Study Arms (2)

INVESTIGATIONAL DRUG

ACTIVE COMPARATOR

oral metformin treatment with 2000Mg daily: Glucophage 500mg Tablet (2-0-2) daily for 1 year

Drug: Metformin Glucophage 500mg (IR) tablets M90

COMPARATIVE DRUG

PLACEBO COMPARATOR

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

Drug: Placebo Oral Tablet

Interventions

Metformin Glucophage 500mg (IR) tablets M90DRUG

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

Also known as: Glucophage (Merck)
INVESTIGATIONAL DRUG
Placebo Oral TabletDRUG

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

Also known as: Placebo (Merck)
COMPARATIVE DRUG

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Infrarenal AAA of 3-4.9 cm maximum diameter

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna, Department of Surgery, Division of Vascular Surgery

Vienna, 1090, Austria

Location

Related Publications (3)

  • minimale Endnote Formatierung der Refs im Word Dokument probieren!!!

    BACKGROUND

  • Klopf J, Willixhofer R, Ahmadi-Fazel D, Scheuba A, Fuchs L, Sotir A, Wanhainen A, Brostjan C, Neumayer C, Eilenberg W. MetAAA Trial Patients Receiving Metformin Therapy Show Limited Improvement in Quality of Life Compared to AAA Patients with Placebo Intake-A Double-Blind, Randomized, and Placebo-Controlled Trial. Med Sci (Basel). 2025 Nov 15;13(4):273. doi: 10.3390/medsci13040273.

    PMID: 41283274DERIVED

  • Klopf J, Willixhofer R, Scheuba A, Fuchs L, Sotir A, Wanhainen A, Brostjan C, Neumayer C, Eilenberg W. MetAAA trial patients show superior quality of life compared to patients under regular surveillance for small AAA: a single-center retrospective cohort study. Int J Surg. 2023 Apr 1;109(4):861-869. doi: 10.1097/JS9.0000000000000343.

    PMID: 36999821DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Metformin

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Christoph Neumayer, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

  • Wolf-Hans Eilenberg, MD, PhD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: prospective, randomized, double blind, placebo-controlled, safety and efficacy study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD

Study Record Dates

First Submitted

March 29, 2018

First Posted

April 25, 2018

Study Start

September 26, 2018

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

March 28, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)