How GLP-1 and GIP medications affect colonoscopy bowel cleansing
The Impact of GLP-1 Agonist and GIP Agonist on Bowel Preparation Quality: A Randomized Controlled Trial
PHASE4 · The Cleveland Clinic · NCT07127354
This test will see if taking GLP‑1 or GIP medications affects bowel cleansing for adults getting an outpatient colonoscopy.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic (other) |
| Locations | 3 sites (Cleveland, Florida and 2 other locations) |
| Trial ID | NCT07127354 on ClinicalTrials.gov |
What this trial studies
This Phase 4 trial will enroll adults on a stable dose of a GLP‑1 or GIP agonist who are scheduled for outpatient colonoscopy. Participants will either hold or continue a single pre-procedure dose of their GLP‑1/GIP medication while following the USMSTF-recommended bowel preparation regimen. The study will compare rates of inadequate bowel preparation and record any complications such as gastric aspiration between the groups. All procedures and follow-up visits will occur at Cleveland Clinic sites in Florida.
Who should consider this trial
Good fit: Adults 18 or older scheduled for an outpatient screening, surveillance, or diagnostic colonoscopy who have been on a stable dose of a GLP‑1 or GIP agonist for at least one month and can follow the prescribed bowel prep are ideal candidates.
Not a fit: Patients with other major risk factors for poor bowel preparation, those who refuse the recommended bowel prep regimen, or those unable to provide informed consent are unlikely to receive benefit from participation.
Why it matters
Potential benefit: If positive, the results could give clear guidance on whether withholding GLP‑1/GIP before colonoscopy improves cleansing and reduces the need for repeat procedures.
How similar studies have performed: Existing evidence is mostly case reports and observational data linking GLP‑1 agonists to delayed gastric emptying, while randomized or large comparative data on colonoscopy prep quality are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Cleveland, Florida and 2 other locations
- Cleveland Clinic — Cleveland, Florida, United States (RECRUITING)
- Cleveland Clinic — Cleveland, Florida, United States (RECRUITING)
- Cleveland Clinic Weston — Weston, Florida, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: GLP - 1, Bowel Preparation for Colonoscopy, GLP-1, Bowel preparation for colonoscopy