Gastric Intestinal Metaplasia
Conditions
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.
Interventions
DRUGMetformin
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.
DRUGFolate
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.
Sponsors
Xijing Hospital of Digestive Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 glucose | 6 months | Fasting blood glucose in mg/dL. |
| 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. |
| 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. |
| LDL-cholesterol | 6 months | LDL-cholesterol in mg/dL. |
| Blood urea nitrogen (BUN) | 6 months | Blood urea nitrogen (BUN) in mg/dL. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes of gastric mucosal bile acid profile in metformin group before the therapy and at the end point. | 6 months | Investigators evaluate the changes of gastric mucosal bile acid profile in metformin group before the therapy and at the end point according to the results of UPLC-MS/MS and pathological. |
| Changes of gastric microbiota in metformin group before the therapy and at the end point. | 6 months | Investigators explore the changes of gastric microbiota in metformin group before the therapy and at the end point according to the results of 16s rRNA sequencing. |
Countries
China
Outcome results
None listed