The Impact of GLP Medication on Colonoscopy Bowel Preparation Quality

NeuroTherapia, Inc.

Status and phase: Enrolling; Phase 4

Conditions: Bowel Preparation for Colonoscopy; GLP - 1

Treatments: Drug: Continue GLP/GIP

Study type: Interventional

Funder types: Other

Identifiers

NCT07127354

25-509

Details and patient eligibility

About

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?

Enrollment: 132 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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132 participants in 2 patient groups

Continue GLP/GIP medication

Active Comparator group

Description:

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

Treatment:

Drug: Continue GLP/GIP

Hold medication

No Intervention group

Description:

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