[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599427":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":58,"collaborators":26,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":26,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":26,"enrollmentInfo":70,"targetDuration":26,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":84,"whyStopped":26,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"General Hospital of Shenyang Military Region","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Lac+PEG-ELS group","EXPERIMENTAL","Oral lactulose combined with PEG-ELS",[13,14],"Drug: lactulose","Drug: PEG (solution given 4 L)",{"label":16,"type":17,"description":18,"interventionNames":19},"PEG-ELS group","ACTIVE_COMPARATOR","Only PEG-ELS",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","lactulose","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.\n2. One Day Before the Colonoscopy: The patients should take 30mL of lactulose orally at 7:00 PM.\n3. On the Day of the Colonoscopy:\n\nFor Morning Appointments:The patients should take 30mL of lactulose orally at 2:00 AM.\n\nFor Afternoon Appointments:The patients should take 30mL of lactulose orally at 7:00 AM.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"PEG (solution given 4 L)","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.\n2. On the Day of the Colonoscopy:\n\nFor Morning Appointments: The patients should take 2000mL of PEG solution at 3:00 AM and drink the entire solution within 2 hours.\n\nFor Afternoon Appointments: The patients should take 2000mL of PEG solution at 7:00 AM and drink the entire solution within 2 hours.",[9,16],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Xingshun Qi","CONTACT","18909881019","xingshunqi@126.com",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Bing Li","13464839718","1749321144@qq.com",[42],{"facility":43,"status":26,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)","Shenyang","Liaoning","110840","China","CN",{"type":50,"coordinates":51},"Point",[52,53],123.43278,41.79222,{"lat":53,"lon":52},[56,57],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},{"type":59,"investigatorFullName":33,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Director of Department of Gastroenterology","100599427","combination-of-lactulose-and-polyethylene-glycol-electrolytes-powder-peg-els-for-bowel-preparation-in-type-ii-diabetes-mellitus-patients-100599427",false,"NCT07084350","Combination of Lactulose and Polyethylene Glycol Electrolytes Powder (PEG-ELS) for Bowel Preparation in Type II Diabetes Mellitus Patients","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","Inclusion Criteria:\n\n1. age 18\\~75 years;\n2. patients undergoing colonoscopy;\n3. diagnosis of type II diabetes mellitus；\n4. sign the informed consent form.\n\nExclusion Criteria:\n\n1. severe heart, lung or liver diseases;\n2. bowel resection;\n3. intestinal obstruction and massive ascites;\n4. women preparing for pregnancy or those who were pregnant and lactating;\n5. mental disorders;\n6. dysphagia;\n7. allergy to any medication used for bowel preparation;\n8. have used prokinetic agents (such as domperidone or mosapride) within 14 days prior to the colonoscopy;\n9. galactose or fructose intolerance, lactase deficiency, galactosemia, or glucose-galactose malabsorption syndrome.","ALL","18 Years",{"count":71,"type":72},254,"ESTIMATED","INTERVENTIONAL",[75],"NA","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.",[78],"Type II Diabetes Mellitus",[80,81,82,83],"Type II diabetes mellitus","Bowel preparation","Lactulose","Polyethylene glycol","NOT_YET_RECRUITING","2025-08-10",{"date":87,"type":88},"2025-08-14","ACTUAL",{"date":90,"type":72},"2025-08-25",{"date":92,"type":72},"2026-07-25",{"name":5,"class":6},1]