Metformin for Abdominal Aortic Aneurysm
(LIMIT Trial)
Trial Summary
What is the purpose of this trial?
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?
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking medications for diabetes. It's best to discuss your current medications with the trial team to see if they might affect your eligibility.
What evidence supports the effectiveness of the drug Metformin for treating abdominal aortic aneurysm?
Is Metformin generally safe for humans?
Metformin, also known as Glucophage, is widely used and generally considered safe for treating conditions like type 2 diabetes and gestational diabetes. It is often combined with other medications, like sitagliptin, to improve blood sugar control, and has been approved by the FDA for these uses.678910
How does the drug metformin differ from other treatments for abdominal aortic aneurysm?
Metformin is unique because it is primarily used as a diabetes medication but has shown potential in slowing the growth of abdominal aortic aneurysms, which is not a standard treatment for this condition. Unlike other treatments, metformin may reduce the risk of aneurysm enlargement and rupture-related mortality, offering a novel approach to managing this condition.123511
Research Team
Ronald Dalman, MD
Principal Investigator
Stanford University
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive metformin or placebo, with dosage increasing weekly over the first month
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Metformin
- Placebo
Metformin is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Type 2 diabetes
- Type 2 diabetes
- Type 2 diabetes
- Type 2 diabetes
- Type 2 diabetes
- Type 2 diabetes
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
VA Palo Alto Health Care System
Collaborator
Kaiser Permanente
Collaborator