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NCT04500756 · ClinicalTrials.gov registry record · Phase 2
Limiting AAA With Metformin (LIMIT) Trial
A Phase 2 study of Abdominal Aortic Aneurysm, sponsored by Stanford University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 314
- Enrollment target
- 1
- Study location
NCT04500756: Recruiting Phase 2 study of Abdominal Aortic Aneurysm, sponsored by Stanford University.
NCT04500756 is a Phase 2 study of Abdominal Aortic Aneurysm that is actively recruiting participants, run by Stanford University. The registered enrollment target is 314 participants, below the 434-participant average among 16 other Abdominal Aortic Aneurysm trials with a reported enrollment target (28% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04500756, a Phase 2 study of Abdominal Aortic Aneurysm, is actively recruiting participants, sponsored by Stanford University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 314 participants
- Enrollment target
- 1
- Study location
Study 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?
Primary Outcome
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 tha
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Metformin
Study Locations (1)
California
- Stanford Hospital and Clinics - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 314 participants |
| Start Date | 2022-02-28 |
| Est. Completion | 2028-06-30 |
| Phase | Phase 2 |
What NCT04500756 shows while recruiting
NCT04500756 is an interventional study that assigns participants to a tested intervention. The registered 314 participants enrollment target is mid-sized for trials with a published cap, below the 434-participant average among 16 other Abdominal Aortic Aneurysm trials with a reported enrollment target (28% lower).
The record links to 1 condition, with Abdominal Aortic Aneurysm appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04500756 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04500756 about?
NCT04500756 is a clinical study titled "Limiting AAA With Metformin (LIMIT) Trial". 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...
What is the current status of trial NCT04500756?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 314 participants. The study started on 2022-02-28. Estimated completion is 2028-06-30.
What conditions does trial NCT04500756 study?
This clinical trial studies the following conditions: Abdominal Aortic Aneurysm.
What interventions are being tested in trial NCT04500756?
The interventions under investigation include: Placebo (OTHER), Metformin (DRUG).
Who is sponsoring clinical trial NCT04500756?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04500756 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04500756's enrollment target sits among peer trials
314 8th of 16 higher than 9 of 16 other Abdominal Aortic Aneurysm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Abdominal Aortic Aneurysm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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