Discontinuation Recommendations for GLP-1 Receptor Agonists Prior to Colonoscopy
ConditionGLP-1
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorFu Jen Catholic University Hospital
About this trial
This study aims to evaluate the impact of different discontinuation intervals of GLP-1 receptor agonists prior to colonoscopy on bowel preparation quality and the need for repeat colonoscopy, in order to establish appropriate discontinuation recommendations.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals who are scheduled to undergo total colonoscopy for any reasons
Age between 18 to 70 years.
ECOG Performance status is 0 or 1.
Written consent to participate in the study has been obtained.
Disqualifiers
• Presence of severe comorbid conditions that preclude the safe performance of colonoscopy (e.g., unstable angina, recent myocardial infarction, decompensated heart failure, chronic respiratory disease, or bleeding diathesis).
History of prior gastric, small bowel, or colorectal segmental resection (patients with isolated appendectomy are eligible).
Family history of hereditary colorectal cancer syndromes.
Current or prior diagnosis of inflammatory bowel disease.
Trial design
Design model
Parallel
Treatments tested in this trial
GLP-1 not stop for 1 week
BehavioralGLP-1 not stop for 1 week
GLP-1 stop for 1 week
BehavioralGLP-1 stop for 1 week
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: GLP-1 stop for 1 weekActive comparator 1 intervention
Group B: GLP-1 not stop for 1 weekPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
.Incomplete bowel preparation rate(IBP) through BBPS(Boston Bowel Preparation Scale)
Effect： Primary outcome: 1.Incomplete bowel preparation rate(IBP) through BBPS(Boston Bowel Preparation Scale) (Total BBPS score \< = 5 or score \<= 1 in any segment) Secondary outcomes: 1. Adenoma detection rate (ADR) 2. Detection rate number of advanced adenomas and colorectal serrated lesions 3. Time for scope insertion to cecum and withdrawal from the cecum to rectum. 4. Incidence of adverse events during colonoscopy 5. Weight gain or HSS was recorded after stopping GLP-1 and before colonoscopy
Time frame
"From enrollment to the end of Procedure and follow up for 30 days"Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
FJUHRecruiting24352, New Taipei, Taiwan
Taiwan
TaiwanSponsors and contacts
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Source ClinicalTrials.gov