Metformin Efficacy and Safety for Gastric Intestinal Metaplasia

NCT05288153 | Completed Phase 4

• 1 other identifier: KY20212212-C-1
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Rate of reversal and progression of gastric intestinal metaplasia

  To evaluate the effects of the therapies, each subject was assigned a stage score before the therapy (A) and at the end point (B) according to OLGIM stages.

  6 months

Secondary Outcomes (9)

• Rate of reversal and progression of gastric atrophy

  6 months

• Fasting blood glucose

  6 months

• Fasting blood insulin

  6 months

• HbA1c

  6 months

• Total cholesterol

  6 months

Other Outcomes (2)

• Changes of gastric mucosal bile acid profile in metformin group before the therapy and at the end point.

  6 months

• Changes of gastric microbiota in metformin group before the therapy and at the end point.

  6 months

Study Arms (2)

the metformin group

EXPERIMENTAL

Patients in the metformin group shall receive oral metformin at 500 mg per day for 6 months.

Drug: Metformin

the folate group

ACTIVE COMPARATOR

Patients in the folate group shall receive oral folate at 5 mg three times a day for 6 months.

Drug: Folate

Interventions

Metformin DRUG

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.

Also known as: Glucophage

the metformin group

Folate DRUG

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.

the folate group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• History of diabetes mellitus (use of medication and/or HbA1c over 6.5%);
• History of regular use (defined as at least once per week) of NSAIDs and/or aspirin;
• History of stomach surgery (including endoscopic submucosal dissection and endoscopic mucosal resection) or previously diagnosed malignant tumor;
• History of heart failure, renal failure, liver cirrhosis or chronic hepatic failure;
• Patients with contraindications or allergies to the drugs in this study;
• Breastfeeding or pregnancy;
• History of substance abuse or alcohol abuse in the past 1 year;
• Severe mental illness;
• Refusal of drug treatment;
• Refusal of signing informed consent.

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (2)

Xijing Hosipital of Digestive Disease

Xi'an, Shaanxi, 710032, China

Location

Xijing hospital

Xi'an, Shaanxi, China

Location

Related Publications (1)

• Li S, Li X, Zhu X, Zhao X, Qu X, Lin K, Yao N, Wang N, Chen M, Zhang L, Shi Y. Therapeutic effect of metformin on reversing gastric intestinal metaplasia. Chin Med J (Engl). 2025 Jun 16. doi: 10.1097/CM9.0000000000003675. Online ahead of print.

  PMID: 40518567 DERIVED

MeSH Terms

Interventions

Metformin; Folic Acid

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yongquan Shi, PhD

  Xijing Hospital of Digestive Diseases

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: March 21, 2022
• Study Start: April 1, 2022
• Primary Completion: May 31, 2023
• Study Completion: October 31, 2023
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)