The Impact of GLP Medication on Colonoscopy Bowel Preparation Quality

NCT07127354 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 25-509
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 3

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 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?

Conditions

GLP - 1; Bowel Preparation for Colonoscopy

Keywords

GLP-1; Bowel preparation for colonoscopy

Outcome Measures

Primary Outcomes (1)

• Rate of inadequate bowel preparation

  During Surgery

Secondary Outcomes (9)

• Median Boston bowel prep score

  During Surgery

• Median Ottawa bowel preparation score

  During Surgery

• Adenoma detection rate

  During Surgery

• Colonoscope Insertion time

  During Surgery

• Withdrawal time

  During Surgery

Study Arms (2)

Continue GLP/GIP medication

ACTIVE COMPARATOR

Patient maintains dose, frequency, duration of medication prior to colonoscopy.

Drug: Continue GLP/GIP

Hold medication

NO INTERVENTION

Withholds prior dose of GLP-1 or GIP therapy per ASA guidance recommendations

Interventions

Continue GLP/GIP DRUG

Continue GLP-1 or GIP-based therapy as prescribed prior to the procedure.

Continue GLP/GIP medication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Cirrhosis
• Parkinson's disease
• Dementia
• Tricyclic antidepressant use
• Opioid use
• 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)
• Previous colorectal surgery
• Prior history of inadequate bowel preparation

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (3)

Cleveland Clinic

Cleveland, Florida, 44195, United States

RECRUITING

Cleveland Clinic

Cleveland, Florida, 44195, United States

RECRUITING

Cleveland Clinic Weston

Weston, Florida, 33331, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 17, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-11

Locations

US (3)