Metformin Efficacy and Safety for Gastric Intestinal Metaplasia

• Status: Not yet recruiting
• Trial end date: 2023-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xijing Hospital of Digestive Diseases
• Treatments: Metformin

Criteria

Inclusion Criteria:

1. Patients aged from 18 to 75 years old;

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

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

4. 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.

Exclusion Criteria:

1. History of diabetes mellitus (use of medication and/or HbA1c over 6.5%);

2. History of regular use (defined as at least once per week) of NSAIDs and/or aspirin;

3. History of stomach surgery (including endoscopic submucosal dissection and endoscopic mucosal resection) or previously diagnosed malignant tumor;

4. History of heart failure, renal failure, liver cirrhosis or chronic hepatic failure;

5. Patients with contraindications or allergies to the drugs in this study;

6. Breastfeeding or pregnancy;

7. History of substance abuse or alcohol abuse in the past 1 year;

8. Severe mental illness;

9. Refusal of drug treatment;

10. Refusal of signing informed consent.