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

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What is this study about?

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.

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 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 initial assessment

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

4 interim analysis

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

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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Region Oerebro Laen	Orebro	Sweden
Region Vaesterbotten	Umea	Sweden
Region Dalarna	Falun	Sweden
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Karolinska University Hospital	Solna	Sweden
Roskilde University	Roskilde	Denmark
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Region Halland	Varberg	Sweden
Soedersjukhuset AB	Stockholm	Sweden
Aoyzyndfi Uzq	Amsterdam	The Netherlands
Ucuzmkp Usayetmidf Htydjrmh	Uppsala	Sweden
Roaofg Vekjobawy	Karlstad	Sweden

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	12.02.2020
Sweden	Recruiting	12.02.2020
The Netherlands	Recruiting	12.02.2020

Trial locations

Investigated drugs:

Metformin Embonate

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.

Investigated diseases:

Aortic aneurysm

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 ID:

2024-517387-37-00

Protocol code:

MAAAGI

NCT ID:

NCT04224051

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?