The Impact of GLP Medication on Colonoscopy Bowel Preparation Quality
NCT ID: NCT07127354
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
132 participants
INTERVENTIONAL
2025-08-01
2026-08-31
Brief Summary
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* 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 any differences in the rates of complications gastric aspiration in patients who hold vs. continue a single dose of their GLP-1 or GIP agonist medication?
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Continue 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.
Hold medication
Withholds prior dose of GLP-1 or GIP therapy per ASA guidance recommendations
No interventions assigned to this group
Interventions
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Continue GLP/GIP
Continue GLP-1 or GIP-based therapy as prescribed prior to the procedure.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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The Cleveland Clinic
OTHER
Responsible Party
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Shah,Tilak
Principal Investigator
Locations
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Cleveland Clinic
Cleveland, Florida, United States
Cleveland Clinic
Cleveland, Florida, United States
Cleveland Clinic Weston
Weston, Florida, United States
Countries
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Facility Contacts
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Other Identifiers
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25-509
Identifier Type: -
Identifier Source: org_study_id
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