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Metformin Efficacy and Safety for Gastric Intestinal Metaplasia

Primary Purpose

Gastric Intestinal Metaplasia

Status
Active
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Metformin
Folate
Sponsored by
Xijing Hospital of Digestive Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Intestinal Metaplasia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xijing Hosipital of Digestive Disease
  • Xijing hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

the metformin group

the folate group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Fasting blood glucose
Fasting blood glucose in mg/dL.
Fasting blood insulin
Fasting blood insulin in μU/mL.
HbA1c
HbA1c in a percentage form.
Total cholesterol
Total cholesterol in mg/dL.
LDL-cholesterol
LDL-cholesterol in mg/dL.
Blood urea nitrogen (BUN)
Blood urea nitrogen (BUN) in mg/dL.
Creatinine
Creatinine in mg/dL.
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.

Full Information

First Posted
February 15, 2022
Last Updated
May 31, 2023
Sponsor
Xijing Hospital of Digestive Diseases
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1. Study Identification

Unique Protocol Identification Number
NCT05288153
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
May 31, 2023 (Actual)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital of Digestive Diseases

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Intestinal Metaplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the metformin group
Arm Type
Experimental
Arm Description
Patients in the metformin group shall receive oral metformin at 500 mg per day for 6 months.
Arm Title
the folate group
Arm Type
Active Comparator
Arm Description
Patients in the folate group shall receive oral folate at 5 mg three times a day for 6 months.
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
Glucophage
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Folate
Intervention Description
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 Outcome Measure Information:
Title
Rate of reversal and progression of gastric intestinal metaplasia
Description
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 Outcome Measure Information:
Title
Rate of reversal and progression of gastric atrophy
Description
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
Title
Fasting blood glucose
Description
Fasting blood glucose in mg/dL.
Time Frame
6 months
Title
Fasting blood insulin
Description
Fasting blood insulin in μU/mL.
Time Frame
6 months
Title
HbA1c
Description
HbA1c in a percentage form.
Time Frame
6 months
Title
Total cholesterol
Description
Total cholesterol in mg/dL.
Time Frame
6 months
Title
LDL-cholesterol
Description
LDL-cholesterol in mg/dL.
Time Frame
6 months
Title
Blood urea nitrogen (BUN)
Description
Blood urea nitrogen (BUN) in mg/dL.
Time Frame
6 months
Title
Creatinine
Description
Creatinine in mg/dL.
Time Frame
6 months
Title
physical examination findings
Description
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 Pre-specified Outcome Measures:
Title
Changes of gastric mucosal bile acid profile in metformin group before the therapy and at the end point.
Description
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
Title
Changes of gastric microbiota in metformin group before the therapy and at the end point.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongquan Shi, PhD
Organizational Affiliation
Xijing Hospital of Digestive Diseases
Official's Role
Study Director
Facility Information:
Facility Name
Xijing Hosipital of Digestive Disease
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Facility Name
Xijing hospital
City
Xi'an
State/Province
Shaanxi
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Metformin Efficacy and Safety for Gastric Intestinal Metaplasia

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