Metformin Efficacy and Safety for Gastric Intestinal Metaplasia: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Rate of reversal and progression of gastric intestinal metaplasia
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
the metformin group
Patients in the metformin group shall receive oral metformin at 500 mg per day for 6 months.
干预措施: Metformin (Drug)
the folate group
Patients in the folate group shall receive oral folate at 5 mg three times a day for 6 months.
干预措施: Folate (Drug)
结局指标
主要结局
Rate of reversal and progression of gastric intestinal metaplasia
时间窗: 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.
次要结局
- Total cholesterol(6 months)
- LDL-cholesterol(6 months)
- Blood urea nitrogen (BUN)(6 months)
- Fasting blood glucose(6 months)
- Rate of reversal and progression of gastric atrophy(6 months)
- Fasting blood insulin(6 months)
- HbA1c(6 months)
- Creatinine(6 months)
- physical examination findings(6 months)
研究者
Yongquan Shi
Clinical Professor
Xijing Hospital of Digestive Diseases