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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
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.
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.
Xijing Hosipital of Digestive Disease
Xi'an, Shaanxi, China
Xijing hospital
Xi'an, Shaanxi, China
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.
Time frame: 6 months
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.
Time frame: 6 months
Fasting blood glucose
Fasting blood glucose in mg/dL.
Time frame: 6 months
Fasting blood insulin
Fasting blood insulin in μU/mL.
Time frame: 6 months
HbA1c
HbA1c in a percentage form.
Time frame: 6 months
Total cholesterol
Total cholesterol in mg/dL.
Time frame: 6 months
LDL-cholesterol
LDL-cholesterol in mg/dL.
Time frame: 6 months
Blood urea nitrogen (BUN)
Blood urea nitrogen (BUN) in mg/dL.
Time frame: 6 months
Creatinine
Creatinine in mg/dL.
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Time frame: 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.
Time frame: 6 months