Metformin Efficacy and Safety for Gastric Intestinal Metaplasia

Gastric Intestinal Metaplasia Clinical Trial

Official title:

Metformin Efficacy and Safety for Gastric Intestinal Metaplasia: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05288153
• Other study ID #: KY20212212-C-1
• Status: Completed
• Phase: Phase 4
• Start date: April 1, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: December 2023
• Source: Xijing Hospital of Digestive Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: October 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 ?-? 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.

Related Conditions & MeSH terms

• Gastric Intestinal Metaplasia
• Metaplasia

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Xijing Hosipital of Digestive Disease	Xi'an	Shaanxi
China	Xijing hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital of Digestive Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Changes of gastric microbiota in metformin group before the therapy and at the end point.	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
Primary	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
Secondary	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
Secondary	Fasting blood glucose	Fasting blood glucose in mg/dL.	6 months
Secondary	Fasting blood insulin	Fasting blood insulin in µU/mL.	6 months
Secondary	HbA1c	HbA1c in a percentage form.	6 months
Secondary	Total cholesterol	Total cholesterol in mg/dL.	6 months
Secondary	LDL-cholesterol	LDL-cholesterol in mg/dL.	6 months
Secondary	Blood urea nitrogen (BUN)	Blood urea nitrogen (BUN) in mg/dL.	6 months
Secondary	Creatinine	Creatinine in mg/dL.	6 months
Secondary	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