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

Status: Completed
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

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

• Patients aged from 18 to 75 years old;

• Body mass index (BMI) ranged from 18.5 to 23.9 at enrollment;

• IM patients with OLGIM stage Ⅱ-Ⅲ diagnosed by upper gastrointestinal endoscopy and histopathological biopsy within the last 3 months;

• Patients without H. pylori infection confirmed by 13C-urea breath test (UBT) or patients with H. pylori infection who completed the bismuth-containing quadruple program and had confirmed successful eradication by 13C-UBT.

Locations
Other Locations
China
Xijing Hosipital of Digestive Disease
Xi'an
Xijing hospital
Xi'an
Time Frame
Start Date: 2022-04-01
Completion Date: 2023-10-31
Participants
Target number of participants: 140
Treatments
Experimental: the metformin group
Patients in the metformin group shall receive oral metformin at 500 mg per day for 6 months.
Active_comparator: the folate group
Patients in the folate group shall receive oral folate at 5 mg three times a day for 6 months.
Related Therapeutic Areas
Sponsors
Leads: Xijing Hospital of Digestive Diseases

This content was sourced from clinicaltrials.gov