Status:
COMPLETED
Metformin Efficacy and Safety for Gastric Intestinal Metaplasia
Lead Sponsor:
Xijing Hospital of Digestive Diseases
Conditions:
Gastric Intestinal Metaplasia
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 sup...
Eligibility Criteria
Inclusion
- Patients aged from 18 to 75 years old;
- 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;
- 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
- History of diabetes mellitus (use of medication and/or HbA1c over 6.5%);
- History of regular use (defined as at least once per week) of NSAIDs and/or aspirin;
- History of stomach surgery (including endoscopic submucosal dissection and endoscopic mucosal resection) or previously diagnosed malignant tumor;
- History of heart failure, renal failure, liver cirrhosis or chronic hepatic failure;
- Patients with contraindications or allergies to the drugs in this study;
- Breastfeeding or pregnancy;
- History of substance abuse or alcohol abuse in the past 1 year;
- Severe mental illness;
- Refusal of drug treatment;
- Refusal of signing informed consent.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2023
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT05288153
Start Date
April 1 2022
End Date
October 31 2023
Last Update
September 23 2024
Active Locations (2)
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1
Xijing Hosipital of Digestive Disease
Xi'an, Shaanxi, China, 710032
2
Xijing hospital
Xi'an, Shaanxi, China