Metformin Efficacy and Safety for Gastric Intestinal Metaplasia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: the metformin group Patients in the metformin group shall receive oral metformin at 500 mg per day for 6 months. |
Drug: 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.
Other Names:
|
| Active Comparator: the folate group Patients in the folate group shall receive oral folate at 5 mg three times a day for 6 months. |
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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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.
Other Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients aged from 18 to 75 years old;
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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;
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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:
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History of diabetes mellitus (use of medication and/or HbA1c over 6.5%);
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History of regular use (defined as at least once per week) of NSAIDs and/or aspirin;
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History of stomach surgery (including endoscopic submucosal dissection and endoscopic mucosal resection) or previously diagnosed malignant tumor;
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History of heart failure, renal failure, liver cirrhosis or chronic hepatic failure;
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Patients with contraindications or allergies to the drugs in this study;
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Breastfeeding or pregnancy;
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History of substance abuse or alcohol abuse in the past 1 year;
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Severe mental illness;
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Refusal of drug treatment;
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Refusal of signing informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Xijing Hosipital of Digestive Disease | Xi'an | Shaanxi | China | 710032 |
Sponsors and Collaborators
- Xijing Hospital of Digestive Diseases
Investigators
- Study Director: Yongquan Shi, PhD, Xijing Hospital of Digestive Diseases
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KY20212212-C-1