In short
A new clinical trial is exploring the potential of Metformin Embonate, a medication typically used for diabetes management, in treating small abdominal aortic aneurysms (AAAs). This study aims to determine if daily doses of Metformin can slow the growth rate of AAAs in patients without diabetes, potentially offering a new treatment option for this cardiovascular condition.
At a glance
- Study Title
- Metformin for Abdominal Aortic Aneurysm Inhibition (MAAAGI)
- Main Objective
- Investigate if 2g metformin daily reduces growth rate of small abdominal aortic aneurysms
- Study Duration
- 60 months (5 years) with interim analysis at 24 months
- Participant Criteria
- Men and women with small AAA, no diabetes history, normal fasting glucose
- Primary Endpoint
- Change in AAA diameter measured by CT imaging
- Secondary Endpoints
- AAA volume changes, quality of life, cost-effectiveness, safety
- Drug Information
- Metformin Embonate, 2000mg daily, oral administration
What is Metformin Embonate?
Metformin Embonate, also known as Metformin hemiembonate or Metformin pamoate, is a medication currently being studied for its potential to slow the growth of small abdominal aortic aneurysms. It's important to note that this drug is still in the research phase and is not yet approved for general use in treating aneurysms.
Metformin is a well-known medication commonly used to treat type 2 diabetes. However, in this study, researchers are exploring its potential benefits for people without diabetes who have a specific heart condition.
Target Condition: Small Abdominal Aortic Aneurysm
The condition being studied is called a small abdominal aortic aneurysm (AAA). An abdominal aortic aneurysm is a bulge or swelling in the main blood vessel (aorta) that runs from your heart through your abdomen. It's considered "small" when it measures:
- 30-49 mm in diameter for men
- 30-44 mm in diameter for women
These small aneurysms are typically monitored through a process called active surveillance, meaning they're regularly checked to see if they're growing.
Research Objectives
The main goal of this research is to determine if Metformin Embonate can slow down the growth of small abdominal aortic aneurysms in people who don't have diabetes. Specifically, the study aims to:
- Investigate if taking 2 grams of metformin daily for 60 months (5 years) can reduce the yearly growth rate of small AAAs.
- Check if this dosage of metformin is safe and tolerable for patients.
- Assess how the treatment affects patients' quality of life.
- Examine if metformin influences biological markers (biomarkers) associated with aortic aneurysms.
- Evaluate if this could be a cost-effective treatment option for patients with small AAAs.
Eligibility Criteria
To participate in this study, patients must meet certain criteria. Here are some key points:
Inclusion Criteria:
- Both men and women can participate
- Must have a documented AAA measuring 30-49 mm for men or 30-44 mm for women
- No history of diabetes and a fasting blood glucose level less than 7.0 mmol/L
- Must provide written informed consent
Exclusion Criteria:
- History of diabetes
- Current or previous use of metformin
- Certain kidney, liver, or heart conditions that could make metformin use unsafe
- Pregnancy or unwillingness to use effective contraception during the study (for women who can become pregnant)
- Participation in other clinical trials within 30 days before this study
Study Endpoints
The researchers will measure the success of the treatment in several ways:
- Primary Endpoint: The main measure will be the change in AAA diameter after 24 and 60 months of treatment, compared to the start of the study. This will be measured using computed tomography (CT) imaging.
- Secondary Endpoints: These include:
- Changes in AAA volume (measured by CT)
- Changes in AAA diameter (measured by ultrasound)
- Improvements in health-related quality of life
- Cost-effectiveness of the treatment in reducing the need for AAA surgery
- Safety assessments, including monitoring for side effects
Dosage and Administration
In this study, participants will receive:
- A daily dose of 2 grams (2000 mg) of Metformin Embonate
- The medication will be taken orally (by mouth)
- The treatment period is planned for 60 months (5 years)
Safety Considerations
Patient safety is a crucial aspect of this study. The researchers will be closely monitoring for any side effects or unexpected reactions. Some important safety points include:
- A safety analysis will be conducted at 24 months to ensure the treatment is safe and effective.
- Patients with certain health conditions that could increase the risk of side effects from metformin are not eligible for the study.
- The study will monitor for known side effects of metformin as well as any unexpected effects on the AAA.
It's important to remember that this is a research study, and Metformin Embonate is not yet approved for treating abdominal aortic aneurysms. If you have concerns about an AAA or are interested in this research, please consult with your healthcare provider for personalized medical advice.