Type II Diabetes Mellitus
Conditions
Keywords
Type II diabetes mellitus, Bowel preparation, Lactulose, Polyethylene glycol
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.).
Interventions
DRUGlactulose
1. Two days before the colonoscopy: The patients should respectively take 30mL of lactulose orally on an empty stomach in the morning and at 8:00 PM of the same day, respectively. 2. One Day Before the Colonoscopy: The patients should take 30mL of lactulose orally at 7:00 PM. 3. On the Day of the Colonoscopy: For Morning Appointments:The patients should take 30mL of lactulose orally at 2:00 AM. For Afternoon Appointments:The patients should take 30mL of lactulose orally at 7:00 AM.
1. One Day Before the Colonoscopy: The patients should take 2000mL of PEG solution at 8:00 PM, and drink the entire solution within 2 hours. 2. On the Day of the Colonoscopy: For Morning Appointments: The patients should take 2000mL of PEG solution at 3:00 AM and drink the entire solution within 2 hours. For Afternoon Appointments: The patients should take 2000mL of PEG solution at 7:00 AM and drink the entire solution within 2 hours.
Sponsors
General Hospital of Shenyang Military Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adequate Bowel Preparation Rate | 3 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Outcome results
None listed