Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT04224051
Eligibility 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. Fasting p-glucose \<7.0 mmol/L. Fasting is defined as no caloric intake for ≥8 h.
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. Contraindications to metformin treatment according to SmPC
6. Known or suspected connective tissue disorder (Marfans syndrome, etc), infected or inflammatory aneurysm, aneurysm development after aortic dissection or previous surgery of the infrarenal aorta.
7. Enrollment 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 enrollment of the current study.
8. If, in the opinion of the investigator, it is not in the patient's medical interest to participate in the study or the patient is unlikely to be able to comply with the study protocol.
9. Pregnancy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT04224051
Study Brief:
Protocol Section:
NCT04224051