Metformin Efficacy and Safety for Gastric Intestinal Metaplasia

NCT ID: NCT05288153

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2023-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

the metformin group

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

Group Type: EXPERIMENTAL

Metformin

Intervention Type: 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.

the folate group

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

Group Type: ACTIVE_COMPARATOR

Folate

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Glucophage

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital of Digestive Diseases

OTHER

Sponsor Role: lead

Responsible Party

Yongquan Shi

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yongquan Shi, PhD

Role: STUDY_DIRECTOR

Xijing Hospital of Digestive Diseases

Locations

Xijing Hosipital of Digestive Disease

Xi'an, Shaanxi, China

Xijing hospital

Xi'an, Shaanxi, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 40518567 (View on PubMed)

Other Identifiers

KY20212212-C-1

Identifier Type: -

Identifier Source: org_study_id