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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the metformin group | Experimental | Patients in the metformin group shall receive oral metformin at 500 mg per day for 6 months. |
|
| the folate group | Active Comparator | Patients in the folate group shall receive oral folate at 5 mg three times a day for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of gastric mucosal bile acid profile in metformin group before the therapy and at the end point. | 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. | 6 months |
| Changes of gastric microbiota in metformin group before the therapy and at the end point. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yongquan Shi, PhD | Xijing Hospital of Digestive Diseases | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hosipital of Digestive Disease | Xi'an | Shaanxi | 710032 | China | ||
| Xijing hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40518567 | Derived | Li S, Li X, Zhu X, Zhao X, Qu X, Lin K, Yao N, Wang N, Chen M, Zhang L, Shi Y. Therapeutic effect of metformin on reversing gastric intestinal metaplasia. Chin Med J (Engl). 2025 Jun 16. doi: 10.1097/CM9.0000000000003675. Online ahead of print. |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D011622 |
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|
| Folate | Drug | 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. |
|
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 |
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. |
| 6 months |
| Xi'an |
| Shaanxi |
| China |
| Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |