NCT05288153

Metformin Efficacy and Safety for Gastric Intestinal Metaplasia

Metformin Efficacy and Safety for Gastric Intestinal Metaplasia: a Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Xijing Hospital of Digestive Diseases · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Gastric intestinal metaplasia significantly increases the risk of gastric cancer. Metformin, a biguanide, which is widely used for treating diabetes mellitus, has recently been suggested to have a suppressive effect on tumorigenesis and cancer cell growth. The investigators devised a prospective randomized controlled trial to evaluate the chemopreventive effect of metformin against gastric intestinal metaplasia and the safety of this drug in non-diabetic gastric intestinal metaplasia patients.

Conditions

• Gastric Intestinal Metaplasia

Interventions

Type	Name	Description
DRUG	Metformin	Subjects will be instructed to take one tablet(500mg) of metformin after breakfast every day, and to visit the hospital every 4 weeks for evaluation of the subjective symptoms and for receiving a new supply of medication.
DRUG	Folate	Subjects will be instructed to take one tablet(5mg) of folate three times every day, and to visit the hospital every 4 weeks for evaluation of the subjective symptoms and for receiving a new supply of medication.

Timeline

• Start date: 2022-04-01
• Primary completion: 2023-05-31
• Completion: 2023-10-31
• First posted: 2022-03-21
• Last updated: 2024-09-23

Locations

2 sites across 1 country: China