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Completed

NCT Number: NCT05288153

Metformin Efficacy and Safety for Gastric Intestinal Metaplasia

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.

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Key information

Conditions

Gastric Intestinal Metaplasia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Xijing Hosipital of Digestive Disease, Xi'an, Shaanxi, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

metformin

Drug

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.

Other names: Glucophage

Folate

Drug

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.

Primary outcomes

  1. Rate of reversal and progression of gastric intestinal metaplasia

    Time frame: 6 months

    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.

Secondary outcomes

  1. Rate of reversal and progression of gastric atrophy

    Time frame: 6 months

    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.

  2. Fasting blood glucose

    Time frame: 6 months

    Fasting blood glucose in mg/dL.

  3. Fasting blood insulin

    Time frame: 6 months

    Fasting blood insulin in μU/mL.

  4. HbA1c

    Time frame: 6 months

    HbA1c in a percentage form.

  5. Total cholesterol

    Time frame: 6 months

    Total cholesterol in mg/dL.

  6. LDL-cholesterol

    Time frame: 6 months

    LDL-cholesterol in mg/dL.

  7. Blood urea nitrogen (BUN)

    Time frame: 6 months

    Blood urea nitrogen (BUN) in mg/dL.

  8. Creatinine

    Time frame: 6 months

    Creatinine in mg/dL.

  9. physical examination findings

    Time frame: 6 months

    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.

Other outcomes

  1. Changes of gastric mucosal bile acid profile in metformin group before the therapy and at the end point.

    Time frame: 6 months

    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.

  2. Changes of gastric microbiota in metformin group before the therapy and at the end point.

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Xijing Hospital of Digestive Diseases

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 21, 2022
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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