Combination of Lactulose and Polyethylene Glycol Electrolytes Powder (PEG-ELS) for Bowel Preparation in Type II Diabetes Mellitus Patients
- Conditions
- Type II Diabetes Mellitus
- Interventions
- Registration Number
- NCT07084350
- Lead Sponsor
- General Hospital of Shenyang Military Region
- Brief Summary
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.
- Detailed Description
Overall, 254 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.).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 254
- age 18~75 years;
- patients undergoing colonoscopy;
- diagnosis of type II diabetes mellitus;
- sign the informed consent form.
- 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;
- dysphagia;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lac+PEG-ELS group lactulose Oral lactulose combined with PEG-ELS PEG-ELS group PEG (solution given 4 L) Only PEG-ELS Lac+PEG-ELS group PEG (solution given 4 L) Oral lactulose combined with PEG-ELS
- Primary Outcome Measures
Name Time Method Adequate Bowel Preparation Rate 3 days
- Secondary Outcome Measures
Name Time Method Adenoma and/or polyp detection rate (ADR/PDR) 3 days Adverse reactions rate associated with bowel preparation 3 days
Trial Locations
- Locations (1)
Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
🇨🇳Shenyang, Liaoning, China
Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)🇨🇳Shenyang, Liaoning, ChinaXingshun QiContact18909881019xingshunqi@126.comBing LiContact134648397181749321144@qq.com