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Metformin for Abdominal Aortic Aneurysm Growth Inhibition (MAAAGI)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04224051
Recruitment Status : Recruiting
First Posted : January 13, 2020
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Jon Unosson, Uppsala University Hospital

Brief Summary:
A multi-centre population-based open-label randomized controlled trial with allocation concealment and blinded outcome assessment will examine if up to 2g metformin daily slows AAA growth in patients with small AAAs who do not have diabetes.

Condition or disease Intervention/treatment Phase
Abdominal Aortic Aneurysm Drug: Metformin Other: Standard care Phase 2

Detailed Description:

Subjects with no history of diabetes will be recruited from a cohort of patients with diagnosed AAA and a maximum aortic diameter of 30-49mm for men and 30-44mm for women.

A total of 500 subjects with AAA will be included in the study, 250 in each study arm. Patients will be randomised to metformin or standard care in a 1:1 ratio.

CT imaging and AAA US will be performed at baseline, 24 months and end of study, as well as if necessary according to clinical routine. Study drug will start at baseline and continue through completion.

When all enrolled subjects have completed the 24-month follow-up (including imaging) an interim analysis will be performed to assess for efficacy and safety; if there is no trend towards a positive effect or signs of a harmful effect of metformin, the study will be stopped at this phase.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metformin for AAA Growth Inhibition, a Randomized Controlled Trial
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2026
Estimated Study Completion Date : January 2026


Arm Intervention/treatment
Experimental: Metformin target dose of 2g daily
Metformin tablets taken orally with target dose of 2g daily plus standard care
Drug: Metformin
Metformin target dose 2 g daily

Active Comparator: Standard care
Standard care includes help with smoking cessation if applicable; encouragement of physical activity and a healthy diet; blood pressure control; statin and anti-platelet therapy treatment if the patient have clinical manifestations of atherosclerotic disease.
Other: Standard care
Abdominal aortic aneurysm surveillance




Primary Outcome Measures :
  1. Abdominal aortic aneurysm (AAA) diameter growth rate [ Time Frame: 5 years ]
    To examine if up to 2g metformin administered daily over a five-year period slows AAA growth measured as computed tomography (CT) imaging assessed AAA diameter (mm) in patients with small AAAs who do not have diabetes.


Secondary Outcome Measures :
  1. Abdominal aortic aneurysm (AAA) volume growth rate [ Time Frame: 5 years ]
    To examine if up to 2g metformin administered daily over a five-year period slows AAA growth measured as computed tomography (CT) imaging assessed AAA volume (ml) in patients with small AAAs who do not have diabetes.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of written informed consent.
  2. Male and female patients.
  3. Age 50-80 years.
  4. Documented AAA Ø 30-49 mm for men and 30-44 mm for women.
  5. Fasting p-glucose <7.0 mmol/L. Fasting is defined as no caloric intake for ≥8 h.

Exclusion Criteria:

  1. Short expected survival.
  2. History of current or previous diabetes mellitus.
  3. Current or previous use of metformin.
  4. Not expected to tolerate metformin.
  5. Contraindications to metformin treatment according to SmPC
  6. Known or suspected connective tissue disorder (Marfans syndrome, etc), infected or inflammatory aneurysm, aneurysm development after aortic dissection or previous surgery of the infrarenal aorta.
  7. Enrollment in either another investigational drug or medical device study or another investigational study of an approved drug or medical device within 30 days prior to enrollment of the current study.
  8. If, in the opinion of the investigator, it is not in the patient's medical interest to participate in the study or the patient is unlikely to be able to comply with the study protocol.
  9. Pregnancy.

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): NCT04224051


Contacts
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Contact: Jon Unosson, PhD +46186110000 jon.unosson@surgsci.uu.se
Contact: Anders Wanhainen, PhD anders.wanhainen@surgsci.uu.se

Locations
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Sweden
Uppsala University Hospital Recruiting
Uppsala, Sverige, Sweden
Contact: Jon Unosson         
Sponsors and Collaborators
Uppsala University Hospital
Investigators
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Principal Investigator: Jon Unosson, PhD Uppsala University Hospital

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Responsible Party: Jon Unosson, MD PhD, Uppsala University Hospital
ClinicalTrials.gov Identifier: NCT04224051    
Other Study ID Numbers: MAAAGI
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
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
Product Manufactured in and Exported from the U.S.: No
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