Efficacy and Safety of Oral Lactulose Combined With Polyethylene Glycol Electrolytes Powder (PEG-ELS) for Bowel Preparation in Type II Diabetes Mellitus Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Adequate Bowel Preparation Rate
研究概览
简要总结
Compared to the general population, diabetic patients have a significantly higher rate of inadequate bowel preparation. The European Society of Gastrointestinal Endoscopy (ESGE) guideline recommends polyethylene glycol (PEG) as the preferred bowel-cleansing agent, but there is currently no standardized bowel preparation protocol specifically for diabetic patients. Previous studies have shown that oral lactulose-based regimens or adding lactulose to the standard PEG protocol can improve bowel preparation quality, reduce adverse effects such as abdominal pain, bloating, nausea, and vomiting, and have no impact on blood glucose levels in diabetic patients after consuming 20g or 30g of lactulose. Herein, a multicenter randomized controlled trial(RCT) has been designed to explore the efficacy and safety of lactulose combined with polyethylene glycol electrolyte solution (PEG-ELS) for bowel preparation in patients with type II diabetes mellitus.
详细描述
Overall, 300 patients with type II diabetes mellitus will be enrolled. They will be randomly assigned at a ratio of 1:1 to the PEG group and lactulose +PEG group. The primary endpoint is the percentage of adequate bowel preparation. Secondary endpoints include the detection rates of polyps or adenomas and the incidence adverse reactions associated with bowel preparation (nausea, vomiting, abdominal pain, bloating, etc.).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18~75 years;
- •patients undergoing colonoscopy;
- •diagnosis of type II diabetes mellitus；
- •sign the informed consent form.
排除标准
- •severe heart, lung or liver diseases;
- •bowel resection;
- •intestinal obstruction and massive ascites;
- •women preparing for pregnancy or those who were pregnant and lactating;
- •mental disorders;
- •allergy to any medication used for bowel preparation;
- •have used prokinetic agents (such as domperidone or mosapride) within 14 days prior to the colonoscopy;
- •galactose or fructose intolerance, lactase deficiency, galactosemia, or glucose-galactose malabsorption syndrome.
研究组 & 干预措施
PEG-ELS group
Only PEG-ELS
干预措施: PEG (solution given 4 L) (Drug)
Lac+PEG-ELS group
Oral lactulose combined with PEG-ELS
干预措施: PEG (solution given 4 L) (Drug)
Lac+PEG-ELS group
Oral lactulose combined with PEG-ELS
干预措施: lactulose (Drug)
结局指标
主要结局
Adequate Bowel Preparation Rate
时间窗: 3 days
次要结局
- Excellent Bowel Preparation Rate(3 days)
- Adenoma and/or polyp detection rate (ADR/PDR)(3 days)
- Adverse reactions rate associated with bowel preparation(3 days)
研究者
Xingshun Qi
Director of Department of Gastroenterology
General Hospital of Shenyang Military Region