Actively Recruiting
Limiting AAA With Metformin (LIMIT) Trial
Led by Stanford University · Updated on 2025-04-18
314
Participants Needed
1
Research Sites
330 weeks
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
K
Kaiser Permanente
Collaborating Sponsor
AI-Summary
What this Trial Is About
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?
CONDITIONS
Official Title
Limiting AAA With Metformin (LIMIT) Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent provided
- Willingness to comply with all study procedures and be available for the study duration
- Male or female aged 50 to 95 years inclusive
- Maximal orthogonal infrarenal aortic diameter between 35 and less than 50 mm for males, and between 30 and less than 45 mm for females, as measured by CT aortography
- Estimated glomerular filtration rate (eGFR) of at least 30 ml/min/1.73 m2 at study start and maintained throughout the study
- Hemoglobin A1c (HgbA1c) of 6.5% or less at study start
- Ability and willingness to take oral medication and adhere to the regimen during the trial
- Willingness and ability to undergo two CT aortogram scans (at start and end of study)
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening, and agreement to continue during the study and for 4 weeks after study drug ends
You will not qualify if you...
- Diagnosis of or treatment for diabetes mellitus with HgbA1c above 6.5% at baseline
- Known allergy or hypersensitivity to metformin hydrochloride
- History of anaphylactic reaction to iodinated contrast (unless opting for CT scan without contrast)
- Metabolic acidosis as indicated by low total CO2 on blood chemistry
- Expected survival less than two years
- Prior surgical repair of abdominal aortic aneurysm or planned repair within two years
- Known thoracic aortic aneurysm disease (prior dissection or thoracic aortic diameter greater than 5 cm)
- Known syndromic aortic conditions such as Ehlers Danlos, Marfan Syndromes, or ACTA2 gene mutation
- Severe liver disease, jaundice, or active hepatitis
- Severe anemia with hemoglobin below 10 g/dl
- Participation in other investigational drug trials
- For females of childbearing potential: pregnancy, intent to become pregnant, breastfeeding, or unwillingness to use effective contraception
- Alcoholism or chronic excessive alcohol use
- Common iliac artery aneurysms larger than 3.5 cm
- Uncontrolled hypertension with systolic blood pressure 200 or higher, or hypertensive emergency or urgency
AI-Screening
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Trial Site Locations
Total: 1 location
1
Stanford Hospital and Clinics
Stanford, California, United States, 94305
Actively Recruiting
Research Team
S
Sohrab Sami
CONTACT
R
Ronald Dalman, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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