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The Impact of GLP Medication on Colonoscopy Bowel Preparation Quality Phase 4 132 Single Dose

Recruiting
Clinical Trial NCT07127354 is designed to study Treatment for GLP - 1, Bowel Preparation for Colonoscopy. It is a Phase 4 interventional study that is recruiting, having started on August 1, 2025, with plans to enroll 132 participants. Led by The Cleveland Clinic, it is expected to complete by August 1, 2026. The latest data from ClinicalTrials.gov was last updated on December 4, 2025.
Brief Summary

The goal of this clinical trial is to learn how GLP-1 and GIP agonists effect bowel preparation in patients scheduled for colonoscopies. The main questions it aims to answer are:

  • Does GLP-1 and GIP agonist increase the rate of inadequate bowel preparation?
  • Does the quality of bowel preparation differ in patients who hold vs. those who continue a single dose of their GLP-1 or GIP agonist medication?
  • Are there a...
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Official Title

The Impact of GLP-1 Agonist and GIP Agonist on Bowel Preparation Quality: A Randomized Controlled Trial

Conditions
GLP - 1Bowel Preparation for Colonoscopy
Other Study IDs
  • 25-509
NCT ID Number
NCT07127354
Start Date (Actual)
2025-08-01
Last Update Posted
2025-12-04
Completion Date (Estimated)
2026-08
Enrollment (Estimated)
132
Study Type
Interventional
PHASE
Phase 4
Status
Recruiting
Keywords
GLP-1
Bowel preparation for colonoscopy
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorContinue GLP/GIP medication
Patient maintains dose, frequency, duration of medication prior to colonoscopy.
Continue GLP/GIP
Continue GLP-1 or GIP-based therapy as prescribed prior to the procedure.
No InterventionHold medication
Withholds prior dose of GLP-1 or GIP therapy per ASA guidance recommendations
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Rate of inadequate bowel preparation
During Surgery
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Median Boston bowel prep score
During Surgery
Median Ottawa bowel preparation score
During Surgery
Adenoma detection rate
During Surgery
Colonoscope Insertion time
Time it takes to reach the cecum
During Surgery
Withdrawal time
During Surgery
Total procedure time
During Surgery
Rate of unplanned endotracheal intubation
During Surgery
hospitalization/emergency department evaluation/readmission for hypoxia or pnemonia within 96 hours after the procedure
From the day of the procedure to 96 hours after the procedure
Other serious adverse events
Day of the procedure up to 96 hours after the procedure.
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • Adult patient (Age 18 years or older)
  • Patient scheduled for outpatient screening, surveillance, or diagnostic colonoscopy
  • Using a GLP-1 or GIP agonist at a stable dose for at least one month

  • Unable to provide informed consent, e.g., dementia

  • Patient refuses the USMSTF recommended bowel cleansing regimen for patients with diabetes or obesity (split-dose 4 liters polyethylene glycol + 15 mg bisacodyl the afternoon before; low residue diet 3 days before colonoscopy; clear liquid diet the day before colonoscopy)

  • Risk factors for inadequate bowel preparation besides diabetes and obesity with a likelihood ratio of 1.6 or greater:

    1. Cirrhosis
    2. Parkinson's disease
    3. Dementia
    4. Tricyclic antidepressant use
    5. Opioid use
    6. Gastroparesis* or suspected gastric outlet obstruction on pre-procedure imaging (*defined based on a documented 4-hour solid phase gastric emptying study or prior history of retained gastric contents during upper endoscopy)
    7. Previous colorectal surgery
    8. Prior history of inadequate bowel preparation
The Cleveland Clinic logoThe Cleveland Clinic
Study Responsible Party
Shah,Tilak, Principal Investigator, Principal Investigator, The Cleveland Clinic
No contact data.
3 Study Locations in 1 Countries

Florida

Cleveland Clinic, Cleveland, Florida, 44195, United States
Samita Garg, M.D., Contact, 216-444-7000, [email protected]
Samita Garg, M.D., Principal Investigator
Recruiting
Cleveland Clinic, Cleveland, Florida, 44195, United States
Samita Garg, MD, Contact, 216-444-2386, [email protected]
Samita Garg, MD, Principal Investigator
Recruiting
Cleveland Clinic Weston, Weston, Florida, 33331, United States
Tilak Shah, M.D., Contact, 877.463.2010, [email protected]
Akram Ahmad, M.D., Contact, [email protected]
Tilak Shah, M.D., Principal Investigator
Recruiting