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

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.

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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.).

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Age icon
Age
18 - None
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Gender
All
NCT ID icon
NCT ID
NCT07084350
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Phase
-1
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Status
Recruiting Now
Medical Condition icon
Medical Condition
diabetes type ii

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The Study
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About Clinical Trials
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Your Journey

01
Receiving the medication
You would receive etanercept (Enbrel) twice a week for 12 weeks and then once a week for 12 weeks. Etanercept, as well as study related medical care, is provided at no cost.
02
Visiting the study site
Study participation involves approximately 8 visits to your local study center over 6 to 7 months.
03
Follow-up
There would also be a follow-up telephone call 30days after completing the study. No visits are required after participation is complete.

Call 1800-9860-568 now to find out if you are eligible.