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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 2 years
Awards & highlights
LIMIT Trial 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.Check my eligibility
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.See study design
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.
LIMIT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
LIMIT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The measure will be the change in maximal orthogonal diameter of the infrarenal aorta, as measured by computed tomographic (CT) aortography, in centimeters.
Secondary outcome measures
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 moreLIMIT 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
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.
Find a Location
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,838 Previous Clinical Trials
47,851,174 Total Patients Enrolled
VA Palo Alto Health Care SystemFED
87 Previous Clinical Trials
56,383 Total Patients Enrolled
Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,340,875 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have very low levels of hemoglobin in your blood, less than 10 grams per deciliter.I have had or will have surgery for an abdominal aortic aneurysm.My kidney function is good enough to start and continue the trial.Your blood pressure is very high and not well controlled.I am between 55 and 95 years old.You are not expected to live for more than two years.I am willing to have two CT scans with contrast at the start and end of the study.Your blood test shows low levels of total CO2.I am allergic to metformin or have had severe reactions to contrast dye.I am willing and able to have two CT scans with contrast at the start and end of the study.My kidney function is good enough for the study.My aorta's size fits within the specified range for my gender.I have diabetes with an HgbA1c level over 6.5%.I have a condition like Ehlers Danlos or Marfan Syndromes, or a specific gene mutation.I have a known issue with my thoracic aorta being too large or previously ruptured.I have a large aneurysm in my pelvic artery.You drink too much alcohol on a regular basis.I am willing and able to follow all study rules and attend all appointments.Your HgbA1c level must be 6.5% or lower to start taking the study medication.I am between 55 and 90 years old.I can take pills and will follow the medication plan for the trial.I can take pills and will follow the medication plan for the trial.My aorta's size is within the required range for my gender.Your HgbA1c level must be 6.5% or lower to start taking the study medication.I do not have severe liver disease, jaundice, or active hepatitis.
Research Study Groups:
This trial has the following groups:- Group 1: Metformin group
- Group 2: Placebo Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this experiment involve elderly participants?
"The current age range for participants in this study are those between 55 to 90 years old."
Answered by AI
What is Metformin group most often used as medication for?
"Metformin group is not only an effective treatment for exercise, but also type 1 diabetes mellitus, diabetic ketoacidosis, and polycystic ovary syndrome."
Answered by AI
Are participants being enrolling in this research at this time?
"This study, the specifics of which can be found on clinicaltrials.gov, is looking for participants. The first posting was on February 28th, 2022 and the most recent update was on March 3rd, 2022."
Answered by AI
What are the negative health effects of Metformin?
"Metformin group was given a score of 2, as there is evidence pointing to its safety, but not yet its efficacy."
Answered by AI
Can you please list any other times Metformin has been used in medical testing?
"At the moment, there are 180 ongoing clinical trials involving metformin, with 46 of them being in phase 3. Most of the metformin trials are taking place in Pittsburgh, Pennsylvania, but there are also 1677 other locations running metformin trials."
Answered by AI
Which demographics are eligible for this clinical trial?
"To qualify for this study, patients must have an aortic aneurysm, be abdominal, and between the ages of 55 and 90. In total, 480 people will be accepted into the trial."
Answered by AI
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