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Efficacy and safety of a polyethylene glycol electrolyte solution combined with lubiprostone for bowel preparation in type 2 diabetes patients using GLP-1 receptor agonists: a prospective, multicenter, randomized, open-label, blinded endpoint trial

Efficacy and safety of a polyethylene glycol electrolyte solution combined with lubiprostone for bowel preparation in type 2 diabetes patients using GLP-1 receptor agonists: a prospective, multicenter, randomized, open-label, blinded endpoint trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098149
Enrollment
Unknown
Registered
2025-03-03
Start date
2025-03-17
Completion date
Unknown
Last updated
2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Interventions

Intervention Group:3 L PEG fractional lavage + lubiprostone
Control group:3 L PEG for bowel wash

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Participants must meet all of the following 4 conditions: 1.Aged between 18 and 75 years, regardless of gender; 2.Diagnosed with type 2 diabetes and currently receiving GLP-1 receptor agonist treatment for more than 8 weeks (no restrictions on the type of GLP-1 receptor agonist); 3.Plan to undergo colonoscopy (including screening, diagnostic, surveillance colonoscopy); 4.Voluntarily agree to participate in the study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: Any of the following conditions: 1.Known or suspected allergy to bowel preparation drugs, such as PEG or Lubiprostone; 2.Suspected or confirmed bowel obstruction, bowel perforation, or foreign body in the bowel; 3.Toxic megacolon; 4.Uncontrolled hypertension (systolic blood pressure >170 mmHg, diastolic blood pressure >100 mmHg); 5.Shock or hemodynamic instability; 6.Severe electrolyte disturbances; 7.Coagulation disorders (prolonged prothrombin time (PT) greater than 3 seconds above the normal upper limit); 8.Congestive heart failure (New York Heart Association functional class III or IV); 9.Respiratory failure; 10.Decompensated cirrhosis; 11.Severe renal impairment (estimated glomerular filtration rate (eGFR) <30 ml/min); 12.Thoracoabdominal aortic aneurysm; 13.History of stroke, acute myocardial infarction, or unstable angina within the past 6 months; 14.History of colon surgery; 15.Pregnant or breastfeeding women; 16.Use of prokinetic drugs within the past week; 17.If the patient is using a long-acting GLP-1 receptor agonist, the drug discontinuation period exceeds 3 half-lives; 18.Severe constipation (as assessed by the Chronic Constipation Severity Score (CSS), exclusion if the score is greater than 15); 19.Participation in other drug/device studies or in the follow-up period of another drug/device study.

Design outcomes

Primary

MeasureTime frame
Bowel Preparation Adequacy Rate;

Secondary

MeasureTime frame
Boston Bowel Preparation Scale Score;Cecal Intubation Rate;Cecal Intubation Time;Polyp Detection Rate;Adenoma Detection Rate;Tolerability of bowel preparation;The willingness of subjects to undergo similar bowel preparation in the future;

Countries

China

Contacts

Public ContactKai Deng

West China Hospital, Sichuan University

dengkai@wchscu.cn+86 189 8060 6867

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026