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New treatment option for Abdominal Aortic Aneurysm
Official title Limiting AAA With Metformin (LIMIT) Trial
ClinicalTrials.gov ID: NCT04500756
What this study is testing
What is Metformin?
Metformin is an investigational medicine, being studied as a potential treatment for abdominal aortic aneurysm.
Also referred to as AAA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 95
You may be able to join if
- 7.2 1. Provision of signed and dated informed consent;
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 50 to 95 years inclusive;
- Have a maximal orthogonal infrarenal aortic diameter between 35 and \< 50 mm for males and between 30 and \< 45 mm for females as measured by CTA;
- Eligible participants must have an estimated glomerular filtration rate (eGFR) of ≥ 30 ml/min/1.73 m2 at the initiation of trial participation, and...
You likely can't join if
- 1. Diagnosis of, or taking medications for, diabetes mellitus, as defined as HgbA1c \> 6.5% at baseline evaluation; 2. Known hypersensitivity to...
- 1 hour before contrast, 50 mg PO prednisone + 50 mg PO diphenhydramine These individuals will also be given the option of CT scan without contrast if...
See the full eligibility criteria
- 7.2 1. Provision of signed and dated informed consent;
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 50 to 95 years inclusive;
- Have a maximal orthogonal infrarenal aortic diameter between 35 and \< 50 mm for males and between 30 and \< 45 mm for females as measured by CTA;
- Eligible participants must have an estimated glomerular filtration rate (eGFR) of ≥ 30 ml/min/1.73 m2 at the initiation of trial participation, and must remain ≥ 30 ml/min/1.73 m2 throughout the term of the study to...
- HgbA1c must be ≤ 6.5% at initiation to receive study medication;
- Ability to take oral medication and be willing to adhere to the medication regimen throughout the course of the trial;
- Must be willing and able to undergo two computed tomographic aortograms (CTA, with timed intravenous iodinated contrast injections if possible) at initiation and termination of study participation;
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening, with an agreement to use such a method of contraception during study participation and for an...
- 1. Diagnosis of, or taking medications for, diabetes mellitus, as defined as HgbA1c \> 6.5% at baseline evaluation; 2. Known hypersensitivity to metformin hydrochloride. Individuals with known prior anaphylactic...
- 1 hour before contrast, 50 mg PO prednisone + 50 mg PO diphenhydramine These individuals will also be given the option of CT scan without contrast if unwilling to follow the premedication as indicated above; 3. Presence...
The study team makes the final eligibility decision.
Where it's taking place
- Stanford, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 95 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stanford, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.