Limiting AAA With Metformin (LIMIT) Trial

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT04500756
Phase
PHASE2
Status
Recruiting
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Conditions

  • Abdominal Aortic Aneurysm

Eligibility Criteria

Sex
ALL
Age
50 Years - 95 Years
Healthy Volunteers
Not accepted

Interventions

  • Metformin — DRUG
    Smaller studies have suggested that metformin may reduce the rate at which aortic aneurysms enlarge. This study will test this question: does metformin prevent AAAs from growing larger?
  • Placebo — OTHER
    One group will be randomized to receive the study drug Metformin and the other group will receive a placebo

Study Details

In this research, the investigators are looking at the effects of a drug called metformin may have on the growth of abdominal aortic aneurysm (AAA)s. AAA is an abnormal enlargement of the aorta, which is the large artery in the abdomen (stomach area). The enlargement of the aorta carries a risk that it will rupture and cause life-threatening bleeding in the abdomen (belly). In this study the investigators hope to learn how metformin is associated with the enlargement or change in size of the AAA in study participants. Smaller studies have suggested that metformin may reduce the rate at which aortic aneurysms enlarge. This study will test this question: does metformin prevent AAAs from growing larger?

Key Dates

Start date
Feb 28, 2022
Status verified
Apr 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
314 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Metformin group
    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.
  • Placebo Comparator: Placebo Group
    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.

Primary Outcome Measure

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. [ Time Frame: Baseline to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford Hospital and ClinicsStanfordCalifornia94305
Lori McDonnell
[email protected]
650-498-5521
Ronald Dalman, MD
[email protected]
650-725-5227

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By research site
Stanford Hospital and Clinics· Stanford, CA

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