Metformin Efficacy and Safety for Gastric Intestinal Metaplasia

Study Overview
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Brief Summary
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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.

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

Conditions
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Gastric Intestinal Metaplasia

Intervention / Treatment
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* Drug: Metformin
* Drug: Folate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: the metformin group<br>Patients in the metformin group shall receive oral metformin at 500 mg per day for 6 months. | Drug: Metformin<br>* 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.<br>* Other names: Glucophage;|
| Active Comparator: the folate group<br>Patients in the folate group shall receive oral folate at 5 mg three times a day for 6 months. | Drug: Folate<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of reversal and progression of gastric atrophy | 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. | 6 months | 
| Fasting blood glucose | Fasting blood glucose in mg/dL. | 6 months | 
| Fasting blood insulin | Fasting blood insulin in μU/mL. | 6 months | 
| HbA1c | HbA1c in a percentage form. | 6 months | 
| Total cholesterol | Total cholesterol in mg/dL. | 6 months | 
| LDL-cholesterol | LDL-cholesterol in mg/dL. | 6 months | 
| Blood urea nitrogen (BUN) | Blood urea nitrogen (BUN) in mg/dL. | 6 months | 
| Creatinine | Creatinine in mg/dL. | 6 months | 
| physical examination findings | 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. | 6 months |