Metformin for Abdominal Aortic Aneurysm Growth Inhibition

NCT04224051 | Unknown Phase 2

• 1 other identifier: MAAAGI
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

• Abdominal aortic aneurysm (AAA) diameter growth rate

  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.

  5 years

Secondary Outcomes (1)

• Abdominal aortic aneurysm (AAA) volume growth rate

  5 years

Study Arms (2)

Metformin target dose of 2g daily

EXPERIMENTAL

Metformin tablets taken orally with target dose of 2g daily plus standard care

Drug: Metformin

Standard care

ACTIVE COMPARATOR

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

Interventions

Metformin DRUG

Metformin target dose 2 g daily

Metformin target dose of 2g daily

Standard care OTHER

Abdominal aortic aneurysm surveillance

Standard care

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Short expected survival.
• History of current or previous diabetes mellitus.
• Current or previous use of metformin.
• Not expected to tolerate metformin.
• Contraindications to metformin treatment according to SmPC
• 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.
• 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.
• 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.
• Pregnancy.

Sponsors & Collaborators

• Uppsala University Hospital: lead

Study Sites (1)

Uppsala University Hospital

Uppsala, Sverige, Sweden

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Metformin; Standard of Care

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jon Unosson, PhD

  Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: January 1, 2020
• First Posted: January 13, 2020
• Study Start: February 12, 2020
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)