Clinical trial NCT05288153: Metformin Efficacy and Safety for Gastric Intestinal Metaplasia
Official title: Metformin Efficacy and Safety for Gastric Intestinal Metaplasia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastric Intestinal Metaplasia
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Rate of reversal and progression of gastric intestinal metaplasia
timeFrame: 6 months
Secondary outcomes:
measure: Rate of reversal and progression of gastric atrophy
timeFrame: 6 months
measure: Fasting blood glucose
timeFrame: 6 months
measure: Fasting blood insulin
timeFrame: 6 months
measure: HbA1c
timeFrame: 6 months
measure: Total cholesterol
timeFrame: 6 months
measure: LDL-cholesterol
timeFrame: 6 months
measure: Blood urea nitrogen (BUN)
timeFrame: 6 months
measure: Creatinine
timeFrame: 6 months
measure: physical examination findings
timeFrame: 6 months
Other outcomes:
measure: Changes of gastric mucosal bile acid profile in metformin group before the therapy and at the end point.
timeFrame: 6 months
measure: Changes of gastric microbiota in metformin group before the therapy and at the end point.
timeFrame: 6 months
Locations:
city: Xi'an
country: China
facility: Xijing Hosipital of Digestive Disease
state: Shaanxi
city: Xi'an
country: China
facility: Xijing hospital
state: Shaanxi
Study officials:
affiliation: Xijing Hospital of Digestive Diseases
name: Yongquan Shi, PhD
role: STUDY_DIRECTOR
References: