Clinical trial
Metformin Efficacy and Safety for Gastric Intestinal Metaplasia: a Randomized Controlled Trial
Name
KY20212212-C-1
Description
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.
Trial arms
Trial start
2022-04-01
Estimated PCD
2023-05-31
Trial end
2023-10-31
Status
Completed
Phase
Early phase I
Treatment
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.
Arms:
the metformin group
Other names:
Glucophage
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.
Arms:
the folate group
Size
140
Primary endpoint
Rate of reversal and progression of gastric intestinal metaplasia
6 months
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 140, 'type': 'ACTUAL'}}
Updated at
2023-12-13
1 organization
1 product
1 drug
1 indication
Organization
Xijing Hospital of Digestive DiseasesDrug
MetforminIndication
Gastric Intestinal MetaplasiaProduct
Folate