GLP-1NCT07736963
Discontinuation Recommendations for GLP-1 Receptor Agonists Prior to Colonoscopy
A study testing GLP-1 not stop for 1 week and GLP-1 stop for 1 week in people with GLP-1, run by Fu Jen Catholic University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- GLP-1
- What is being tested?
- GLP-1 not stop for 1 week and GLP-1 stop for 1 week
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2026to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Outpatient department patient
- Stop at least 3 days if current using medications that promote or inhibit gastrointestinal motility.
Who cannot join
- • 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.
- Known colorectal polyposis syndromes.
- Any other condition deemed inappropriate for study participation at the discretion of the treating physician.
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- Body mass index (BMI) > 40 kg/m².
- Diagnosis of liver cirrhosis.
- Diagnosis of Parkinson's disease.
- Diagnosis of dementia.
- Use of tricyclic antidepressants or opioid medications for more than 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
FJUH
New Taipei, Taiwan, 24352
Kuan I Sung, 0928139643, danny520julia@gmail.com
About this study
Official title: Discontinuation Recommendations for GLP-1 Receptor Agonists Prior to Colonoscopy: A Randomized Controlled Trial in Taiwan.
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.
Read the detailed description
Background: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have become increasingly prevalent in modern clinical practice, extending their therapeutic roles beyond glycemic control in type 2 diabetes mellitus (T2DM) to encompass weight management, cardiovascular protection, and emerging indications in hepatic diseases. The growing adoption of GLP-1 RAs, including newer agents such as tirzepatide, has highlighted their beneficial effects on metabolic health. However, their pharmacological action of delaying gastric emptying and suppressing gastrointestinal motility has raised concerns regarding their potential impact on bowel preparation quality prior to colonoscopy.
Colonoscopy remains a cornerstone modality for colorectal cancer screening and prevention, where high-quality bowel preparation is essential for adequate mucosal visualization and lesion detection. Inadequate bowel preparation not only compromises diagnostic accuracy but also increases the risk of missed lesions, procedural complications, and necessitates repeat examinations, leading to greater healthcare costs and patient burden. Current guidelines advocate split-dose polyethylene glycol (PEG)-based regimens as the standard for bowel cleansing; however, patient-related factors, including the use of medications that inhibit gastrointestinal motility, are recognized contributors to bowel preparation failure.
GLP-1 RAs are classified as enterogastrones, exerting their effects via the ileal brake mechanism, which slows upper gastrointestinal transit in response to nutrient exposure. While this effect is therapeutically advantageous for glycemic control and weight reduction, it may inadvertently impair bowel cleansing efficacy. Preliminary evidence suggests that GLP-1 RA users are at higher risk of inadequate bowel preparation and repeat colonoscopy. Nonetheless, empirical data regarding optimal peri-procedural management, specifically the appropriate discontinuation interval of GLP-1 RAs prior to colonoscopy, remain scarce.
Given the pharmacokinetic diversity of GLP-1 RAs and their prolonged half-lives, it is unclear how long prior to colonoscopy these agents should be withheld to mitigate their gastrointestinal motility-suppressing effects and reduce the likelihood of suboptimal bowel cleansing. The absence of evidence-based discontinuation guidelines for GLP-1 RAs in this setting represents an unmet clinical need.
This study aims to evaluate the relationship between GLP-1 RA discontinuation intervals and bowel preparation adequacy, Using BBPS(Boston Bowel Preparation Scale) as a surrogate marker for inadequate bowel cleansing. By determining the optimal discontinuation timeframe for GLP-1 RAs, we seek to provide clinically actionable recommendations to optimize colonoscopy outcomes in this growing patient population.
- Conditions
- GLP-1
- Being tested
- GLP-1 not stop for 1 week, GLP-1 stop for 1 week
- Keywords
- GLP-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1 not stop for 1 weekBehavioural
GLP-1 not stop for 1 week
GLP-1 stop for 1 weekBehavioural
GLP-1 stop for 1 week
| Study group | Role | What they receive |
|---|---|---|
| GLP-1 stop for 1 week | Active comparator | GLP-1 stop for 1 week Receives: Behavioral: GLP-1 stop for 1 week |
| GLP-1 not stop for 1 week | Placebo comparator | GLP-1 not stop for 1 week Receives: Behavioral: GLP-1 not stop for 1 week |
What is being measured
The primary outcome is the main question the study is designed to answer.
.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:
- Adenoma detection rate (ADR)
- Detection rate number of advanced adenomas and colorectal serrated lesions
- Time for scope insertion to cecum and withdrawal from the cecum to rectum.
- Incidence of adverse events during colonoscopy
- Weight gain or HSS was recorded after stopping GLP-1 and before colonoscopy
Measured: "From enrollment to the end of Procedure and follow up for 30 days"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Jun 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GLP-1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736963
- Sponsor's protocol ID
- LGI GLP-1
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discontinuation Recommendations for GLP-1 Receptor Agonists Prior to Colonoscopy: A Randomized Controlled Trial in Taiwan.
- ClinicalTrials.gov ID
- NCT07736963
- Acronym / sponsor ID
- LGI GLP-1
- Conditions
- GLP-1
- Keywords
- GLP-1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Fu Jen Catholic University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have become increasingly prevalent in modern clinical practice, extending their therapeutic roles beyond glycemic control in type 2 diabetes mellitus (T2DM) to encompass weight management, cardiovascular protection, and emerging indications in hepatic diseases. The growing adoption of GLP-1 RAs, including newer agents such as tirzepatide, has highlighted their beneficial effects on metabolic health. However, their pharmacological action of delaying gastric emptying and suppressing gastrointestinal motility has raised concerns regarding their potential impact on bowel preparation quality prior to colonoscopy.
Colonoscopy remains a cornerstone modality for colorectal cancer screening and prevention, where high-quality bowel preparation is essential for adequate mucosal visualization and lesion detection. Inadequate bowel preparation not only compromises diagnostic accuracy but also increases the risk of missed lesions, procedural complications, and necessitates repeat examinations, leading to greater healthcare costs and patient burden. Current guidelines advocate split-dose polyethylene glycol (PEG)-based regimens as the standard for bowel cleansing; however, patient-related factors, including the use of medications that inhibit gastrointestinal motility, are recognized contributors to bowel preparation failure.
GLP-1 RAs are classified as enterogastrones, exerting their effects via the ileal brake mechanism, which slows upper gastrointestinal transit in response to nutrient exposure. While this effect is therapeutically advantageous for glycemic control and weight reduction, it may inadvertently impair bowel cleansing efficacy. Preliminary evidence suggests that GLP-1 RA users are at higher risk of inadequate bowel preparation and repeat colonoscopy. Nonetheless, empirical data regarding optimal peri-procedural management, specifically the appropriate discontinuation interval of GLP-1 RAs prior to colonoscopy, remain scarce.
Given the pharmacokinetic diversity of GLP-1 RAs and their prolonged half-lives, it is unclear how long prior to colonoscopy these agents should be withheld to mitigate their gastrointestinal motility-suppressing effects and reduce the likelihood of suboptimal bowel cleansing. The absence of evidence-based discontinuation guidelines for GLP-1 RAs in this setting represents an unmet clinical need.
This study aims to evaluate the relationship between GLP-1 RA discontinuation intervals and bowel preparation adequacy, Using BBPS(Boston Bowel Preparation Scale) as a surrogate marker for inadequate bowel cleansing. By determining the optimal discontinuation timeframe for GLP-1 RAs, we seek to provide clinically actionable recommendations to optimize colonoscopy outcomes in this growing patient population.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLP-1 stop for 1 week | Active comparator | Behavioral: GLP-1 stop for 1 weekGLP-1 stop for 1 week |
| GLP-1 not stop for 1 week | Placebo comparator | Behavioral: GLP-1 not stop for 1 weekGLP-1 not stop for 1 week |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
Key exclusion criteria (11 listed)
- • 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLP-1 not stop for 1 weekGLP-1 not stop for 1 week | Behavioural | GLP-1 not stop for 1 week |
| GLP-1 stop for 1 weekGLP-1 stop for 1 week | Behavioural | GLP-1 stop for 1 week |
Primary outcome
.Incomplete bowel preparation rate(IBP) through BBPS(Boston Bowel Preparation Scale)
Time frame: "From enrollment to the end of Procedure and follow up for 30 days"
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GLP-1 not stop for 1 week and GLP-1 stop for 1 week in people with GLP-1, run by Fu Jen Catholic University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kuan I Sung (+886928139643, ioudanny520@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
.Incomplete bowel preparation rate(IBP) through BBPS(Boston Bowel Preparation Scale) (time frame: "From enrollment to the end of Procedure and follow up for 30 days"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.