Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06405971

Metformin in Patients With Unruptured Vertebrobasilar Dissecting Aneurysms (METTLE)

Led by Ming Lv · Updated on 2025-02-06

60

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Vertebrobasilar dissecting aneurysms (VBDAs) are one of the most important causes of stroke in young and middle-aged people, and the natural history of VBDAs is complex and varied, often leading to high rates of disability and mortality. For some patients with VBDAs who are not suitable for surgical entrapment and intervention, pharmacologic therapy may be used to slow the progression of VBDAs. Metformin (MET) has been shown to act as an anti-inflammatory, anti-oxidative stress and improve vascular endothelial function by inhibiting smooth muscle cell phenotypic transformation, proliferation, migration and apoptosis, thereby reducing the incidence of intracranial aneurysms and rupture rates, and MET may be a suitable candidate. Inflammatory response plays an important role in the occurrence, development and rupture of VBDAs. Inflammatory response in the aneurysm wall can cause endothelial and smooth muscle cell injury and apoptosis, leading to degenerative changes in the vessel wall and increasing the risk of rupture of VBDAs. High-resolution magnetic resonance vessel wall imaging (HR-VWI), which can clearly show the structure of the vessel wall and reflect the active degree of inflammatory reaction in the aneurysm wall, has been widely used in the assessment of intracranial aneurysm instability. In this study, we propose to conduct a multicenter, prospective, randomized study to investigate whether MET reduces the degree of aneurysm wall inflammatory response in VBDAs by performing HR-VWI scans in patients with VBDAs and obtaining quantitative parameters reflecting the inflammatory response of the aneurysm wall.

CONDITIONS

Official Title

Metformin in Patients With Unruptured Vertebrobasilar Dissecting Aneurysms (METTLE)

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 75 years, any gender
  • Untreated, unruptured stable vertebrobasilar dissecting aneurysms confirmed by DSA, CTA, or MRA
  • Aneurysm wall enhancement visible on high-resolution vessel wall MRI at 3.0T strength
  • Baseline modified Rankin Scale (mRS) score of 2 or less
  • Voluntary participation with signed informed consent
Not Eligible

You will not qualify if you...

  • Aneurysms located outside vertebral or basilar arteries (e.g., bifurcation saccular aneurysms)
  • Diabetes or related complications
  • Allergy to any metformin components
  • Pregnant or breastfeeding women
  • Other immune diseases or use of immunosuppressants or anti-inflammatory drugs
  • Severe symptoms at diagnosis with mRS score 3 or higher
  • Previous interventional or surgical treatment for VBDAs
  • Severe allergy to gadolinium-based contrast agents
  • Severe kidney disease with renal insufficiency (GFR <30 ml/min/1.73m2)
  • Presence of metal implants such as stents, prosthetic valves, pacemakers, or non-removable dentures
  • Dementia, psychiatric disorders, or claustrophobia preventing MRI completion
  • Serious diseases with expected survival under 1 year
  • Participation in other drug or device clinical trials
  • Any other conditions deemed unsuitable by investigators

AI-Screening

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Trial Site Locations

Total: 1 location

1

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China, 100010

Actively Recruiting

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Research Team

L

Linggen Dong, MD

CONTACT

M

Ming Lv, Ph D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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