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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
314
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?
One group will be randomized to receive the study drug Metformin and the other group will receive a placebo
Stanford Hospital and Clinics
Stanford, California, United States
RECRUITINGThe primary outcome measure will be the change in maximal orthogonal diameter of the infrarenal aorta, as measured by computed tomographic (CT) aortography, in centimeters.
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.
Time frame: Baseline to 2 years
Profile of Adverse cardiovascular events
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.
Time frame: Baseline to 2 years
Study drug compliance
Pill counts will be used to measure study drug compliance.
Time frame: Baseline to 2 years
All-cause mortality
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.
Time frame: Baseline to 2 years
Change in existing medication regimen as a measure of metformin treatment
Concurrent medication regimen will be tabulated and listed according to the drug classifications
Time frame: Baseline to 2 years
Change in serological markers of the liver as a measure of impact of metformin treatment
Albumin and total protein, total bilirubin, ALT, and AST will be assessed for these serological markers.
Time frame: Baseline to 2 years
Change in serological markers of the kidney as a measure of impact of metformin treatment
Urea nitrogen (BUN) and creatinine will be assessed for these serological markers.
Time frame: Baseline to 2 years
Change in serological markers of the hematopoietic function as a measure of impact of metformin treatment
Complete Blood Count (CBC) will be assessed for this serological marker.
Time frame: Baseline to 2 years
Change from baseline in Living with Abdominal Aortic Aneurysm (AAA) Survey
62 question instrument for evaluating AAA specific Quality of Life
Time frame: Baseline to 2 years
Change from baseline in Short Form (SF-36) health survey
36 question instrument for evaluating Health-Related Quality of Life
Time frame: Baseline to 2 years
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