Metformin in Patients with Unruptured Vertebrobasilar Dissecting Aneurysms (METTLE)

Launched by MING LV · May 6, 2024

Keywords

ClinConnect Summary

The METTLE trial is studying the effects of a medication called Metformin on patients with a specific type of brain aneurysm known as vertebrobasilar dissecting aneurysms (VBDAs). These aneurysms can lead to serious complications like strokes, especially in younger adults. The trial aims to find out if Metformin can help reduce inflammation in the walls of these aneurysms, which may lower the risk of them getting worse or rupturing. Participants will undergo special MRI scans to assess the condition of their aneurysms and how they respond to the treatment.

To be eligible for the trial, participants must be between 18 and 75 years old and have been diagnosed with stable, unruptured VBDAs that have not received previous treatment. They should also have a low level of disability at the start of the study. If someone decides to join the trial, they will receive Metformin and will be closely monitored for changes in their condition through imaging tests. It's important to note that certain health conditions or treatments may exclude someone from participating, so a discussion with a healthcare provider is essential to determine eligibility.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years and ≤75 years, gender is not limited;
• • 2. Patients with previously untreated, unruptured stable VBDAs clearly diagnosed by DSA, CTA or MRA;
• • 3. Patients with aneurysm wall enhancement as shown by HR-VWI of 3.0T high field strength MRI whole body scanner at Tsinghua University;
• • 4. Baseline mRS score ≤2;
• • 5. Patients voluntarily participated in this study and signed an informed consent form.
• Exclusion Criteria:
• • 1. Patients with aneurysms located in non-vertebral basilar artery sites (mainly referring to bifurcation saccular aneurysms);
• • 2. Patients with combined diabetes or its complications;
• • 3. Patients who are allergic to any components in MET;
• • 4. Pregnant and lactating female patients;
• • 5. Patients with other immune diseases in combination, patients taking immunosuppressants or anti-inflammatory drugs (such as long-term use of aspirin, statin, hormones and other drugs);
• • 6. Target aneurysm-related symptoms were severe at the time of diagnosis, and the mRS score was ≥3;
• • 7. VBDAs have received interventional or surgical treatment;
• • 8. Those with severe allergy to the contrast agent gadolinium terlumate glucosamine (Gd-DTPA) (skin rash not counted);
• • 9. Those with severe renal disease resulting in renal insufficiency (glomerular filtration rate \<30ml/(min·1.73m2));
• • 10. Patients with metal implants in the body (e.g., cardiac stents, cardiac prosthetic valves, pacemakers, metal joints, steel plates, non-removable metal dentures, etc.);
• • 11. Patients known to suffer from dementia or psychiatric disorders and claustrophobia who are unable to complete the magnetic resonance examination;
• • 12. Patients with other serious diseases combined at the time of diagnosis and with an expected survival time of less than 1 year;
• • 13. Patients who are participating in clinical trials of other drugs or devices.
• • 14. Other conditions judged by the investigator to exist that are unsuitable for enrollment.