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Study on Metformin Embonate to Slow Growth of Small Abdominal Aortic Aneurysms in Patients Without Diabetes

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication metformin on a condition known as a small abdominal aortic aneurysm (AAA). An abdominal aortic aneurysm is a bulge in the wall of the main blood vessel that carries blood from the heart to the rest of the body. This study is specifically looking at small aneurysms, which are under active surveillance and measure 30-49 mm in diameter for men and 30-44 mm for women.

The purpose of the study is to investigate whether taking 2 grams of metformin daily for five years can slow down the growth rate of these small aneurysms in patients who do not have diabetes. Participants will be monitored over this period, with assessments at the start, after 24 months, and at the end of the study. The study will also look at whether metformin can limit the increase in the size of the aneurysm, improve quality of life, and reduce the need for surgery.

Throughout the study, the safety of metformin will be closely monitored, with particular attention to any side effects or unexpected effects on the aneurysm. The study will also explore if there is a relationship between the dose or duration of metformin treatment and its effects, as well as its impact on inflammation and tissue changes around the blood vessel. An interim analysis will be conducted at 24 months to evaluate safety and effectiveness.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient provides written informed consent. Eligibility includes being between 50-80 years old, having a small abdominal aortic aneurysm (AAA) with specific size criteria, and no history of diabetes.

  2. Step 2

    Medication administration

    The patient begins taking metformin, a medication administered orally. The dosage is 2 grams daily. This treatment continues for a period of 60 months.

  3. Step 3

    Initial assessment

    At the start of the trial, a baseline assessment of the AAA diameter is conducted using computed tomography (CT) imaging.

  4. Step 4

    Interim analysis

    After 24 months of treatment, an interim analysis is performed. This analysis evaluates the safety and effectiveness of the treatment.

  5. Step 5

    Ongoing monitoring

    Throughout the trial, the patient is monitored for any adverse effects related to the metformin treatment. This includes known side effects and any unexpected effects on the AAA.

  6. Step 6

    Final assessment

    At the end of the 60-month treatment period, a final assessment of the AAA diameter is conducted using CT imaging. This is compared to the baseline measurement to determine the effect of the treatment.

  7. Step 7

    Additional evaluations

    Secondary evaluations include examining changes in AAA volume, health-related quality of life, and the cost-effectiveness of the treatment. Exploratory objectives assess the response of metformin on inflammation and tissue changes.

Who can join the trial?

5 criteria

  • Provide written informed consent, which means you agree to participate in the study after understanding all the details.
  • Be either male or female.
  • Be between the ages of 50 and 80 years old.
  • Have a documented **small abdominal aortic aneurysm (AAA)**, which is a bulge in the main blood vessel in the abdomen. For men, it should be 30-49 mm in size, and for women, it should be 30-44 mm in size.
  • Have no history of **diabetes mellitus**, which is a condition where the body has trouble managing blood sugar levels. Your fasting blood sugar level should be less than 7.0 mmol/L.

Who cannot join the trial?

5 criteria

  • Patients with a history of **diabetes** cannot participate. **Diabetes** is a condition where the body has trouble managing blood sugar levels.
  • Patients who are not under active surveillance for a **small abdominal aortic aneurysm (AAA)** cannot participate. An **abdominal aortic aneurysm** is a bulge in the main blood vessel that supplies blood to the abdomen, pelvis, and legs.
  • Patients with an **abdominal aortic aneurysm** that is not within the specified size range cannot participate. For men, the size should be between 30-49 mm, and for women, it should be between 30-44 mm.
  • Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups that may have a higher risk of harm or exploitation.
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Investigated drugs

Metformin is a medication commonly used to manage blood sugar levels in people with type 2 diabetes. In this clinical trial, it is being tested to see if it can slow down the growth of small abdominal aortic aneurysms in patients who do not have diabetes. The trial aims to determine if taking metformin daily for 60 months can reduce the yearly growth rate of these aneurysms.

What is already known about the treatment

Metformin – Metformin is typically administered orally in tablet form. It is a well-established medication primarily used to manage type 2 diabetes, but it is currently being studied for its potential to slow the growth of small abdominal aortic aneurysms in patients without diabetes. The main therapeutic indication in this trial is to reduce the yearly growth rate of these aneurysms. Metformin works by activating an enzyme called AMP-activated protein kinase (AMPK), which plays a role in cellular energy balance and may influence vascular health. It is classified as a biguanide, a type of medication that helps control blood sugar levels.

Investigated diseases

Small Abdominal Aortic Aneurysm (AAA) – This condition involves a bulging or swelling in the abdominal aorta, the large blood vessel that supplies blood to the abdomen, pelvis, and legs. It is considered "small" when the aneurysm measures between 30-49 mm in diameter for men and 30-44 mm for women. Over time, the aneurysm may slowly enlarge, which can increase the risk of complications. The progression of the aneurysm is typically monitored through regular imaging tests to assess changes in size. The condition often remains asymptomatic until it reaches a larger size or causes complications. Regular surveillance is crucial to manage the condition and prevent potential issues.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517387-37-00Protocol codeMAAAGIEstimated enrolment500 patientsSponsorUppsala University

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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