Metformin for Abdominal Aortic Aneurysm (AAA) Growth

This study is investigating whether metformin, a commonly used medication, can prevent abdominal aortic aneurysms (AAAs) from growing larger. An AAA is an abnormal enlargement of the aorta, the main artery in your abdomen (belly). If it grows too large, it can rupture and cause life-threatening bleeding. Previous smaller studies suggest metformin might slow this growth. This research will compare metformin to a placebo (an inactive substance) to see if it can stop AAAs from getting bigger. You may be eligible if you are between 50 and 95 years old and have an AAA within a specific size range (35-50mm for males, 30-45mm for females). The study will measure changes in AAA size over two years to determine if metformin is effective.

Study design
This is an interventional study with a planned enrollment of 314 participants. Participants will be randomly assigned to receive either metformin or a placebo.
What's involved
You would need to provide signed consent and be willing to follow all study procedures and be available for the duration of the study.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, change in AAA size, will be measured from baseline to 2 years.

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NCT04500756

Limiting AAA With Metformin (LIMIT) Trial

Recruiting
PHASE2Ages 50–95InterventionalTreatment
Stanford University
~314 participants
Updated 2025-04-18 on ClinicalTrials.gov
What's tested:MetforminPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The primary outcome measure will be the change in maximal orthogonal diameter of the infrarenal aorta, as measured by computed tomographic (CT) aortography, in centimeters.
Measured over Baseline to 2 years
Abdominal Aortic Aneurysm
1 sites across 1 states
California1
  • Ronald Dalman, MD · PRINCIPAL_INVESTIGATOR · Stanford University

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  • The primary outcome measure will be the change in maximal orthogonal diameter of the infrarenal aorta, as measured by computed tomographic (CT) aortography, in centimeters.Baseline to 2 years

    The change in maximal orthogonal diameter of the infrarenal aorta, as measured by computed tomographic (CT) aortography, over the course of the study in participants taking metformin XR (extended release) vs. placebo. It is calculated as the difference in CTA-determined diameter (in mm) from baseline to the follow-up CT study at the end of study participation, divided by time elapsed between two measurements (e.g., annual rate of change in CT-diameter). The justification for this endpoint is that maximal orthogonal transverse diameter by CTA is the primary standard to measure AAA disease progression, determine need for surgical intervention, and correlate with clinical outcomes.