The Impact of GLP Medication on Colonoscopy Bowel Preparation Quality

NCT ID: NCT07127354

Last Updated: 2025-12-04

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2026-08-31

Brief Summary

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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?

Detailed Description

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Conditions

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GLP - 1 Bowel Preparation for Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Continue GLP/GIP medication

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

Group Type ACTIVE_COMPARATOR

Continue GLP/GIP

Intervention Type DRUG

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

Group Type NO_INTERVENTION

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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Shah,Tilak

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cleveland Clinic

Cleveland, Florida, United States

Site Status RECRUITING

Cleveland Clinic

Cleveland, Florida, United States

Site Status RECRUITING

Cleveland Clinic Weston

Weston, Florida, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Samita Garg, M.D.

Role: primary

216-444-7000

Samita Garg, MD

Role: primary

216-444-2386

Tilak Shah, M.D.

Role: primary

877.463.2010

Akram Ahmad, M.D.

Role: backup

Other Identifiers

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25-509

Identifier Type: -

Identifier Source: org_study_id

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