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Combination of Lactulose and Polyethylene Glycol Electrolytes Powder (PEG-ELS) for Bowel Preparation in Type II Diabetes Mellitus Patients

Not Applicable
Not yet recruiting
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
Inclusion Criteria
  1. age 18~75 years;
  2. patients undergoing colonoscopy;
  3. diagnosis of type II diabetes mellitus;
  4. sign the informed consent form.
Exclusion Criteria
  1. severe heart, lung or liver diseases;
  2. bowel resection;
  3. intestinal obstruction and massive ascites;
  4. women preparing for pregnancy or those who were pregnant and lactating;
  5. mental disorders;
  6. dysphagia;
  7. allergy to any medication used for bowel preparation;
  8. have used prokinetic agents (such as domperidone or mosapride) within 14 days prior to the colonoscopy;
  9. galactose or fructose intolerance, lactase deficiency, galactosemia, or glucose-galactose malabsorption syndrome.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Lac+PEG-ELS grouplactuloseOral lactulose combined with PEG-ELS
PEG-ELS groupPEG (solution given 4 L)Only PEG-ELS
Lac+PEG-ELS groupPEG (solution given 4 L)Oral lactulose combined with PEG-ELS
Primary Outcome Measures
NameTimeMethod
Adequate Bowel Preparation Rate3 days
Secondary Outcome Measures
NameTimeMethod
Adenoma and/or polyp detection rate (ADR/PDR)3 days
Adverse reactions rate associated with bowel preparation3 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, China
Xingshun Qi
Contact
18909881019
xingshunqi@126.com
Bing Li
Contact
13464839718
1749321144@qq.com

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