Small abdominal aortic aneurysm (AAA) under active surveillance
Conditions
Sponsors
Department of Surgical, Sciences Uppsala University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent 2. Male and female patients 3. Age 50-80 years 4. Documented AAA Ø 30-49 mm for men and 30-44 mm for women 5. No history of diabetes mellitus and fasting p-glucose =65 years) yes F.1.3.1 Number of subjects for this age range 400
Exclusion criteria
Exclusion criteria: 1. Short expected survival. 2. History of current or previous diabetes mellitus. 3. Current or previous use of metformin. 4. Not expected to tolerate metformin. 5. Contraindication to metformin according to summary of product characteristics (SmPc in FASS 2019) including: Renal failure with glomerular filtration rate (GFR) <45ml/min, progressing or unstable heart failure, recent myocardial infarction, liver impairment or alcoholism evidenced by patient history or clinical examination. 6. Known or suspected connective tissue disorder (Marfans syndrome, etc), infected or inflammatory aneurysm, aneurysm post aortic dissection or previous surgery of the infrarenal aorta. 7. Enrolled in either another investigational drug or medical device study or another investigational study of an approved drug or medical device within 30 days prior to enrolment of the current study. 8. Any condition or laboratory finding which in the opinion of the Investigator makes the patient unsuitable for inclusion. 9. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate if 2 g metformin daily over 60 months reduce yearly growth rate of small abdominal aortic aneurysms in patients with no history of diabetes At 24 months a Stop/Go interim analysis will be performed for safety and efficacy ;Secondary Objective: To investigate if metformin 2 g per day is tolerable and safe, affects quality of life, affects biomarkers associated with aortic aneurysms and may represent a cost effective medical treatment in patients with a small abdominal aortic aneurysm and no history diabetes;Primary end point(s): To examine if 2 g metformin administered daily over a five-year period slows AAA growth rate in patients with small AAAs who do not have diabetes mellitus measured as computed tomography (CT) imaging assessed AAA diameter. ;Timepoint(s) of evaluation of this end point: Baseline versus 24 and 60 months of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcomes To examine if metformin; a) limits increase in CT-assessed AAA volume; b) ultrasound assessed AAA diameter; c) improve health-related quality of life; and d) represent a cost-effective treatment to reduce the need for AAA surgery. Safety objective To determine adverse events; primarily related to known side effects of metformin and possible unexpected effects on AAA, related to metformin treatment after two and five years treatment. Exploratory objectives To examine; a) if there is a dose or time related response of metformin regarding the primary or secondary endpoints; and b) if metformin favorably modify circulating inflammation and matrix remodeling biomarkers; or c) affect perivascular adipose tissue. ;Timepoint(s) of evaluation of this end point: Baseline versus 24 and 60 months of treatment | — |
Countries
Denmark, Sweden
Contacts
Public ContactPrincipal Investigator
Department of Surgical Sciences
Outcome results
None listed