Limiting AAA With Metformin (LIMIT) Trial
- Registration Number
- NCT04500756
- Lead Sponsor
- Stanford University
- 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?
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 314
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Group Placebo 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. Metformin group Metformin 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 Measures
Name Time Method 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. 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 Outcome Measures
Name Time Method Profile of Adverse cardiovascular events Baseline to 2 years Incidence of adverse cardiovascular events including: unanticipated adverse events (AEs) and serious AEs (SAEs), AEs leading to premature discontinuation from the study intervention and serious treatment-emergent AEs, clinically significant AE events, such as cardiovascular AEs and surgical AAA repairs.
Study drug compliance Baseline to 2 years Pill counts will be used to measure study drug compliance.
All-cause mortality Baseline to 2 years All-cause mortality will be summarized using Kaplan-Meier survival curves for each arm. Participants alive at last follow-up will be censored at last time known alive.
Change in existing medication regimen as a measure of metformin treatment Baseline to 2 years Concurrent medication regimen will be tabulated and listed according to the drug classifications
Change in serological markers of the liver as a measure of impact of metformin treatment Baseline to 2 years Albumin and total protein, total bilirubin, ALT, and AST will be assessed for these serological markers.
Change in serological markers of the kidney as a measure of impact of metformin treatment Baseline to 2 years Urea nitrogen (BUN) and creatinine will be assessed for these serological markers.
Change in serological markers of the hematopoietic function as a measure of impact of metformin treatment Baseline to 2 years Complete Blood Count (CBC) will be assessed for this serological marker.
Change from baseline in Living with Abdominal Aortic Aneurysm (AAA) Survey Baseline to 2 years 62 question instrument for evaluating AAA specific Quality of Life
Change from baseline in Short Form (SF-36) health survey Baseline to 2 years 36 question instrument for evaluating Health-Related Quality of Life
Trial Locations
- Locations (1)
Stanford Hospital and Clinics
🇺🇸Stanford, California, United States