Using Metformin to Treat Unruptured Vertebrobasilar Aneurysms

Metformin in Patients With Unruptured Vertebrobasilar Dissecting Aneurysms: a Prospective, Randomized Study (METTLE)

This study is testing if Metformin, a diabetes medication, can help adults with unruptured vertebrobasilar aneurysms by reducing inflammation and improving blood vessel health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06405971 on ClinicalTrials.gov

What this trial studies

This study investigates the use of Metformin, a medication commonly used for diabetes, in patients with unruptured vertebrobasilar dissecting aneurysms (VBDAs). The research aims to determine if Metformin can reduce inflammation and improve vascular health, potentially slowing the progression of these aneurysms. Participants will be adults aged 18 to 75 with stable, untreated VBDAs diagnosed through advanced imaging techniques. The study will monitor the effects of Metformin on the aneurysm wall and overall patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with untreated, stable unruptured VBDAs diagnosed via imaging.

Not a fit: Patients with diabetes, severe aneurysm-related symptoms, or those allergic to Metformin may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a non-surgical option to manage and potentially reduce the risks associated with unruptured vertebrobasilar aneurysms.

How similar studies have performed: While the use of Metformin in this context is novel, previous studies have shown its potential benefits in vascular health and inflammation, suggesting a promising avenue for further exploration.

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.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Tiantan Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Linggen Dong, MD

Conditions Dissecting Aneurysm of Cerebral Artery; Vertebrobasilar dissecting aneurysms; Metformin; High-resolution vessel wall imaging; Inflammatory reaction