AzTrials
AzTrials

Gastric Intestinal MetaplasiaPhase 4NCT05288153

Metformin Efficacy and Safety for Gastric Intestinal Metaplasia

A Phase 4 study testing Metformin and Folate in people with Gastric Intestinal Metaplasia, run by Xijing Hospital of Digestive Diseases at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastric Intestinal Metaplasia
What is being tested?
Metformin and Folate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
2 sitesChina
Study dates
1 Apr 2022to 31 Oct 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 10Show fewer
  • History of substance abuse or alcohol abuse in the past 1 year;
  • Severe mental illness;
  • Refusal of drug treatment;
  • Refusal of signing informed consent.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Xijing Hosipital of Digestive Disease

    Xi'an, Shaanxi, 710032

  • Xijing hospital

    Xi'an, Shaanxi

Other trials in China

About this study

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

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.

Being tested
Metformin, Folate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MetforminDrug

    Also called Glucophage

    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.

  • FolateDrug

    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.

Study groups in NCT05288153
Study groupRoleWhat they receive
the metformin groupExperimentalPatients in the metformin group shall receive oral metformin at 500 mg per day for 6 months.
Receives: Drug: Metformin
the folate groupActive comparatorPatients in the folate group shall receive oral folate at 5 mg three times a day for 6 months.
Receives: Drug: Folate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (9)

  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.

    Measured: 6 months

  2. Fasting blood glucose

    Fasting blood glucose in mg/dL.

    Measured: 6 months

  3. Fasting blood insulin

    Fasting blood insulin in μU/mL.

    Measured: 6 months

  4. HbA1c

    HbA1c in a percentage form.

    Measured: 6 months

  5. Total cholesterol

    Total cholesterol in mg/dL.

    Measured: 6 months

  6. LDL-cholesterol

    LDL-cholesterol in mg/dL.

    Measured: 6 months

  7. Blood urea nitrogen (BUN)

    Blood urea nitrogen (BUN) in mg/dL.

    Measured: 6 months

  8. Creatinine

    Creatinine in mg/dL.

    Measured: 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2022
  2. Study start1 Apr 2022
  3. Primary completion31 May 2023
  4. Study completion31 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05288153
Sponsor's protocol ID
KY20212212-C-1
Status last verified
Sep 2024
First submitted
15 Feb 2022
Last updated
23 Sep 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li S, Li X, Zhu X, Zhao X, Qu X, Lin K, Yao N, Wang N, Chen M, Zhang L, Shi Y. Therapeutic effect of metformin on reversing gastric intestinal metaplasia. Chin Med J (Engl). 2026 Aug 20;139(16):2450-2458. doi: 10.1097/CM9.0000000000003675. Epub 2025 Jun 16.

    PubMed 40518567

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Metformin and Folate in people with Gastric Intestinal Metaplasia, run by Xijing Hospital of Digestive Diseases at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of reversal and progression of gastric intestinal metaplasia (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05288153, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in