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CompletedNCT05288153Updated Sep 23, 2024

Metformin Efficacy and Safety for Gastric Intestinal Metaplasia

A Phase 4 interventional study of Metformin and Folate in Gastric Intestinal Metaplasia, sponsored by Xijing Hospital of Digestive Diseases. Completed at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-09-23.

Sponsored by Xijing Hospital of Digestive Diseases · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gastric Intestinal Metaplasia

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03

In context

Metaplasia

99 studies on the registry are indexed under Metaplasia; 12 are open to participants now.

This study's enrollment of 140 is above the median of 67 across 49 interventional studies indexed under Metaplasia.

Browse Metaplasia studies →

Lead sponsor

Xijing Hospital of Digestive Diseases is the lead sponsor of 80 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
140 participants (actual)

Study arms

  • Experimental
    the metformin group

    Patients in the metformin group shall receive oral metformin at 500 mg per day for 6 months.

    Drug: Metformin

  • Active comparator
    the folate group

    Patients in the folate group shall receive oral folate at 5 mg three times a day for 6 months.

    Drug: Folate

Interventions

  • DrugMetformin

    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.

    Also known as: Glucophage

  • DrugFolate

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: 6 months

  2. Fasting blood glucose

    Fasting blood glucose in mg/dL.

    Time frame: 6 months

  3. Fasting blood insulin

    Fasting blood insulin in μU/mL.

    Time frame: 6 months

  4. HbA1c

    HbA1c in a percentage form.

    Time frame: 6 months

  5. Total cholesterol

    Total cholesterol in mg/dL.

    Time frame: 6 months

  6. LDL-cholesterol

    LDL-cholesterol in mg/dL.

    Time frame: 6 months

  7. Blood urea nitrogen (BUN)

    Blood urea nitrogen (BUN) in mg/dL.

    Time frame: 6 months

  8. Creatinine

    Creatinine in mg/dL.

    Time frame: 6 months

  9. 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.

    Time frame: 6 months

Other outcomes

  1. 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.

    Time frame: 6 months

  2. 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.

    Time frame: 6 months

07

Study locations

2 sites
  • Xijing Hosipital of Digestive Disease
    Xi'an, Shaanxi 710032, China
  • Xijing hospital
    Xi'an, Shaanxi, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05288153
Lead sponsor
Xijing Hospital of Digestive Diseases
Responsible party
Yongquan Shi (Clinical Professor, Xijing Hospital of Digestive Diseases) — Principal investigator
First posted
Mar 21, 2022
Start date
Apr 1, 2022
Primary completion
May 31, 2023
Completion
Oct 31, 2023
Last update
Sep 23, 2024

Study contacts

Yongquan Shi, PhD
study director · Xijing Hospital of Digestive Diseases

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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