The Impact of GLP Medication on Colonoscopy Bowel Preparation Quality
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Continue GLP/GIP.
- Who it may be relevant to
- Registry conditions: GLP - 1, Bowel Preparation for Colonoscopy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Impact of GLP-1 Agonist and GIP Agonist on Bowel Preparation Quality: A Randomized Controlled Trial
Overview
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?
Interventions
- Drug Continue GLP/GIP
Continue GLP-1 or GIP-based therapy as prescribed prior to the procedure.
Primary outcome measures
- Rate of inadequate bowel preparation [Time frame: During Surgery]
Secondary outcome measures (9)
- Median Boston bowel prep score [Time frame: During Surgery]
- Median Ottawa bowel preparation score [Time frame: During Surgery]
- Adenoma detection rate [Time frame: During Surgery]
- Colonoscope Insertion time [Time frame: During Surgery]
- Withdrawal time [Time frame: During Surgery]
- Total procedure time [Time frame: During Surgery]
- Rate of unplanned endotracheal intubation [Time frame: During Surgery]
- hospitalization/emergency department evaluation/readmission for hypoxia or pnemonia within 96 hours after the procedure [Time frame: From the day of the procedure to 96 hours after the procedure]
- Other serious adverse events [Time frame: Day of the procedure up to 96 hours after the procedure.]
Eligibility 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:
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- Cleveland Clinic — Cleveland
- Cleveland Clinic — Cleveland
- Cleveland Clinic Weston — Weston
Identifiers
NCT: NCT07127354 · 25-509