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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age ≥18 years and ≤75 years, gender is not limited;

• Patients with previously untreated, unruptured stable VBDAs clearly diagnosed by DSA, CTA or MRA;

• Patients with aneurysm wall enhancement as shown by HR-VWI of 3.0T high field strength MRI whole body scanner at Tsinghua University;

• Baseline mRS score ≤2;

• Patients voluntarily participated in this study and signed an informed consent form.

Locations
Other Locations
China
Beijing Tiantan Hospital
RECRUITING
Beijing
Contact Information
Primary
Linggen Dong, MD
donglinggen@163.com
18844738529
Backup
Ming Lv, Ph D.
dragontiger@163.com
13701376177
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2025-06-01
Participants
Target number of participants: 60
Treatments
Experimental: Drug Group
Patients in the drug group were given one oral tablet of metformin hydrochloride enteric capsule each day after breakfast and dinner at a dose of 250 mg per tablet.
Placebo_comparator: Placebo group
Patients in the placebo group were given one oral tablet of placebo (capsule filled with corn starch) each day after breakfast and dinner at a dose of 250 mg per tablet.
Related Therapeutic Areas
Sponsors
Leads: Ming Lv

This content was sourced from clinicaltrials.gov