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Biguanide

Metformin for Abdominal Aortic Aneurysm (LIMIT Trial)

Phase 2

Recruiting

Led By Ronald Dalman, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eligible participants must have an estimated glomerular filtration rate (eGFR) of ≥ 45 ml/min/1.73 m2 at the initiation of trial participation, and must remain ≥ 30 ml/min/1.73 m2 throughout the term of the study to continue participation;

Male or female, aged 55 to 95 years inclusive

Must not have

Prior surgical AAA repair, or anticipated repair within two years

Diagnosis of, or taking medications for, diabetes mellitus, as defined as HgbA1c > 6.5% at baseline evaluation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 2 years

Summary

This trial is testing whether the drug metformin can prevent abdominal aortic aneurysms (AAAs) from growing larger. Smaller studies have suggested that metformin may reduce the rate at which aortic aneurysms enlarge.

Who is the study for?

The LIMIT trial is for men and women aged 55 to 90 with abdominal aortic aneurysms measuring 35-49 mm (men) or 35-45 mm (women). Participants must have stable blood sugar levels (HgbA1c ≤ 6.5%), good kidney function, and be able to take oral medication. Women of childbearing age must use effective contraception.

What is being tested?

This study tests whether metformin can prevent the growth of abdominal aortic aneurysms compared to a placebo. Participants will receive either metformin or a placebo and undergo CT scans at the start and end of the study to measure any changes in their aneurysm size.

What are the potential side effects?

Metformin may cause side effects like stomach upset, diarrhea, muscle pain, low blood sugar levels, and possibly more serious conditions such as lactic acidosis. The risk varies among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function is good enough to start and continue the trial.

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I am between 55 and 95 years old.

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I am willing to have two CT scans with contrast at the start and end of the study.

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My kidney function is good enough for the study.

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My aorta's size fits within the specified range for my gender.

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I am between 55 and 90 years old.

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I can take pills and will follow the medication plan for the trial.

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My aorta's size is within the required range for my gender.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had or will have surgery for an abdominal aortic aneurysm.

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I have diabetes with an HgbA1c level over 6.5%.

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I have a condition like Ehlers Danlos or Marfan Syndromes, or a specific gene mutation.

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I have a known issue with my thoracic aorta being too large or previously ruptured.

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I have a large aneurysm in my pelvic artery.

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I do not have severe liver disease, jaundice, or active hepatitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The measure will be the change in maximal orthogonal diameter of the infrarenal aorta, as measured by computed tomographic (CT) aortography, in centimeters.

Secondary study objectives

All-cause mortality

Change from baseline in Living with Abdominal Aortic Aneurysm (AAA) Survey

Change from baseline in Short Form (SF-36) health survey

+6 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Metformin groupActive Control1 Intervention

Participants will either be assigned to take metformin 500 mg tablet(s) daily or identical tablet(s) that contain no active drug, also taken every day. Over the first four weeks of the study, you will increase your dosage every week by one pill, so at the end of the first month you will be taking up to four pills per day. If you develop any symptoms or side effects from pill ingestion during this process, your dose will be decreased to the last number of pills you were able to take without developing side effects.

Group II: Placebo GroupPlacebo Group1 Intervention

0 / 14Eligibility criteria met