LIMItIng AAA With meTformin (LIMIT) Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Stanford University
- Enrollment
- 314
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief Summary
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?
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
randomized (which means assigned by chance, like flipping a coin) into one of two groups. You 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.
Eligibility Criteria
- Ages
- 50 Years to 95 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Metformin (Drug)
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.
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
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
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.
Secondary Outcomes
- Profile of Adverse cardiovascular events(Baseline to 2 years)
- Study drug compliance(Baseline to 2 years)
- All-cause mortality(Baseline to 2 years)
- Change in existing medication regimen as a measure of metformin treatment(Baseline to 2 years)
- Change in serological markers of the liver as a measure of impact of metformin treatment(Baseline to 2 years)
- Change in serological markers of the kidney as a measure of impact of metformin treatment(Baseline to 2 years)
- Change in serological markers of the hematopoietic function as a measure of impact of metformin treatment(Baseline to 2 years)
- Change from baseline in Living with Abdominal Aortic Aneurysm (AAA) Survey(Baseline to 2 years)
- Change from baseline in Short Form (SF-36) health survey(Baseline to 2 years)
Investigators
Ronald L. Dalman, MD
Division Chief of Stanford Vascular Surgery
Stanford University