Recruiting

GLP-1 & GIP Agonists

Sponsor:

The Cleveland Clinic

Code:

NCT07127354

Conditions

GLP - 1

Bowel Preparation for Colonoscopy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Continue GLP/GIP

Study Details

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

Study ID

NCT07127354

Start date

Aug 1, 2025

Status verified date

Nov, 2025

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

132 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Continue GLP/GIP medication

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

no intervention: Hold medication

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

Interventions

Continue GLP/GIP

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

Primary outcome measure

  • Rate of inadequate bowel preparation [ Time Frame: During Surgery ]

Central Contacts and Locations

Locations

Cleveland Clinic

Recruiting

Cleveland, Florida, United States, 44195

Contacts

Samita Garg, M.D.

216-444-7000GARGS@ccf.org

Principal Investigator:

Samita Garg, M.D.

Cleveland Clinic

Recruiting

Cleveland, Florida, United States, 44195

Contacts

Samita Garg, MD

216-444-2386GARGS@ccf.org

Principal Investigator:

Samita Garg, MD

Cleveland Clinic Weston

Recruiting

Weston, Florida, United States, 33331

Contacts

Tilak Shah, M.D.

877.463.2010SHAHT3@ccf.org

Akram Ahmad, M.D.

ahmada5@ccf.org

Principal Investigator:

Tilak Shah, M.D.

More Information

Sponsor

The Cleveland Clinic

Last update posted

Dec 4, 2025

Last verified

Nov, 2025

Keywords

  • GLP-1
  • Bowel preparation for colonoscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2025-12-04.