LIMItIng AAA With meTformin (LIMIT) Trial

Who is this study for? Patients with abdominal aortic aneurysm
What treatments are being studied? Metformin
Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
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?

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 95
Healthy Volunteers: f
View:

• 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 continue participation;

• 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 additional 4 weeks after the end of study drug administration.

Locations
United States
California
Stanford Hospital and Clinics
RECRUITING
Stanford
Contact Information
Primary
Sohrab Sami
ssami@stanford.edu
412-452-7137
Backup
Ronald Dalman, MD
rld@stanford.edu
650-725-5227
Time Frame
Start Date: 2022-02-28
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 314
Treatments
Active_comparator: Metformin group
Participants will either be assigned to take metformin 500 mg tablet(s) daily or identical tablet(s) that contain no active drug, also taken every day. Over the first four weeks of the study, you will increase your dosage every week by one pill, so at the end of the first month you will be taking up to four pills per day. If you develop any symptoms or side effects from pill ingestion during this process, your dose will be decreased to the last number of pills you were able to take without developing side effects.
Placebo_comparator: Placebo Group
Participants will either be assigned to take metformin 500 mg tablet(s) daily or identical tablet(s) that contain no active drug, also taken every day. Over the first four weeks of the study, you will increase your dosage every week by one pill, so at the end of the first month you will be taking up to four pills per day. If you develop any symptoms or side effects from pill ingestion during this process, your dose will be decreased to the last number of pills you were able to take without developing side effects.
Sponsors
Leads: Stanford University
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), Kaiser Permanente, VA Palo Alto Health Care System

This content was sourced from clinicaltrials.gov