Metformin Efficacy and Safety for Gastric Intestinal Metaplasia

Phase 4

Completed

• Conditions: Gastric Intestinal Metaplasia
• Interventions: Drug: Metformin; Drug: Folate

• Registration Number: NCT05288153
• Lead Sponsor: Xijing Hospital of Digestive Diseases

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-15
• Study First Submitted QC: 2022-03-18
• Study First Posted: 2022-03-21
• Study Start: 2022-04-01
• Primary Completion: 2023-05-31
• Study Completion: 2023-10-31
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-11
• Last Update Posted: 2023-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the metformin group	Metformin	Patients in the metformin group shall receive oral metformin at 500 mg per day for 6 months.
the folate group	Folate	Patients in the folate group shall receive oral folate at 5 mg three times a day for 6 months.

Primary Outcome Measures

Name	Time	Method
Rate of reversal and progression of gastric intestinal metaplasia	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Fasting blood glucose	6 months	Fasting blood glucose in mg/dL.
Rate of reversal and progression of gastric atrophy	6 months	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 OLGA stages.
Fasting blood insulin	6 months	Fasting blood insulin in μU/mL.
HbA1c	6 months	HbA1c in a percentage form.
Total cholesterol	6 months	Total cholesterol in mg/dL.
LDL-cholesterol	6 months	LDL-cholesterol in mg/dL.
Blood urea nitrogen (BUN)	6 months	Blood urea nitrogen (BUN) in mg/dL.
Creatinine	6 months	Creatinine in mg/dL.
physical examination findings	6 months	Physical examination findings included weight in kilograms, height in meters and weight and height will be combined to report body mass index (BMI) in kg/m\^2.

Trial Locations

Locations (2)

Xijing Hosipital of Digestive Disease; 🇨🇳 Xi'an, Shaanxi, China

Xijing hospital; 🇨🇳 Xi'an, Shaanxi, China