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Metformin Therapy in Non-diabetic AAA Patients (MetAAA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03507413
Recruitment Status : Enrolling by invitation
First Posted : April 25, 2018
Last Update Posted : October 24, 2019
Sponsor:
Collaborator:
Merck Serono GmbH, Germany
Information provided by (Responsible Party):
Christoph Neumayer, Medical University of Vienna

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)

Condition or disease Intervention/treatment Phase
Abdominal Aortic Aneurysm Drug: Metformin Glucophage 500mg (IR) tablets M90 Drug: Placebo Oral Tablet Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective, randomized, double blind, placebo-controlled, safety and efficacy study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomized, Double Blind, Placebo-controlled, Safety and Efficacy Study of Metformin as add-on Therapy in Non-diabetic Patients With Abdominal Aortic Aneurysm (MetAAA Study)
Actual Study Start Date : September 26, 2018
Estimated Primary Completion Date : January 15, 2022
Estimated Study Completion Date : November 15, 2022


Arm Intervention/treatment
Active Comparator: INVESTIGATIONAL DRUG
oral metformin treatment with 2000Mg daily: Glucophage 500mg Tablet (2-0-2) daily for 1 year
Drug: Metformin Glucophage 500mg (IR) tablets M90
oral metformin Glucophage treatment 500 mg daily (2-0-2) for 1 year
Other Name: Glucophage (Merck)

Placebo Comparator: COMPARATIVE DRUG
Placebo matching M90 Oral Tablet treatment twice daily (2-0-2) for 1 year
Drug: Placebo Oral Tablet
Placebo Oral Tablet M90 treatment twice daily (2-0-2) for 1 year
Other Name: Placebo (Merck)




Primary Outcome Measures :
  1. AAA growth over 12 months in mm [ Time Frame: 12 months ]
    AAA maximum diameter in CT scan


Secondary Outcome Measures :
  1. inflammation markers IL-6 [ Time Frame: 12 months ]
    inflammatory cytokines and parameters of neutrophil activation in patient plasma

  2. glucose markers insulin and glucose [ Time Frame: 12 months ]
    inflammatory cytokines and parameters of neutrophil activation in patient plasma

  3. neutrophil markers NGAL [ Time Frame: 12 months ]
    inflammatory cytokines and parameters of neutrophil activation in patient plasma

  4. ineutrophil marker MPO [ Time Frame: 12 months ]
    inflammatory cytokines and parameters of neutrophil activation in patient plasma

  5. neutrophil marker elastase [ Time Frame: 12 months ]
    inflammatory cytokines and parameters of neutrophil activation in patient plasma

  6. AAA thrombus [ Time Frame: 12 months ]
    volume of AAA thrombus



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03507413


Locations
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Austria
Medical University of Vienna, Department of Surgery, Division of Vascular Surgery
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Merck Serono GmbH, Germany
Investigators
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Principal Investigator: Christoph Neumayer, MD Medical University of Vienna
Principal Investigator: Wolf-Hans Eilenberg, MD, PhD Medical University of Vienna

Publications:
minimale Endnote Formatierung der Refs im Word Dokument probieren!!!

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Responsible Party: Christoph Neumayer, Professor, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03507413     History of Changes
Other Study ID Numbers: 1479/2017
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christoph Neumayer, Medical University of Vienna:
abdominal aortic aneurysm
metformin
non-diabetic
placebo
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs