Diabetes Mellitus, Type 2Phase 4NCT06533527
Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy
A Phase 4 study testing GLP-1 medication in people with Diabetes Mellitus, Type 2 and Obesity, run by The Cleveland Clinic at 2 sites in United States.
Trial summary
To assess whether holding incretin-based therapy before endoscopy reduces the likelihood of clinically relevant Residual Gastric Volume (RGV). Primary Outcomes: Residual gastric volume that precludes adequate endoscopic examination Residual gastric volume that necessitates premature termination of the endoscopy… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity, Gastroparesis
- What is being tested?
- GLP-1 medication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Jul 2024to 20 May 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients using incretin-based therapies at a stable dose for more than 1 month.
- Patients scheduled for outpatient esophagogastroduodenoscopy (EGD), endoscopic ultrasound (EUS), or endoscopic retrograde cholangiopancreatography (ERCP) under monitored anesthesia care.
Who cannot join
- Documented history of gastroparesis (based on a 4-hour solid-phase gastric emptying study)
- Known history of achalasia
- Surgical or genetically altered foregut anatomy
- Known gastric outlet obstruction or pre-procedure imaging suggestive of gastric outlet obstruction.
- Patients who did not follow the standard NPO (nil per oral) instructions.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cleveland Clinic
Cleveland, Ohio, 44195
Cleveland Clinic
Weston, Florida, 33331
About this study
Official title: Randomized Trial of Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy
To assess whether holding incretin-based therapy before endoscopy reduces the likelihood of clinically relevant Residual Gastric Volume (RGV).
Primary Outcomes:
Read more
- Residual gastric volume that precludes adequate endoscopic examination
- Residual gastric volume that necessitates premature termination of the endoscopy procedure
- Need for endotracheal intubation due to stomach contents.
- Occurrence of aspiration events requiring extended observation/monitoring, unplanned therapeutics, and/or hospital admission
Secondary Outcomes:
- Presence of any solid food
- Presence of moderate liquid content
- Increased RGV(Residual Gastric Volume) defined as any amount of solid content or > 0.8 mL/Kg of fluid content (measured from the aspiration/suction canister).
- Differences in primary and secondary outcomes between different medications
- Conditions
- Diabetes Mellitus, Type 2, Obesity, Gastroparesis
- Being tested
- GLP-1 medication
- Keywords
- incretin, wegovy, ozempic, mounjaro, glp1, gastroparesis, residual gastric volume, endoscopy, anesthesia
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1 medicationDrug
Also called Tirzepatide, Semaglutide, Liraglutide, Dulaglutide
Continue taking GLP-1 as normally scheduled prior to endoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Continue medication as normal prior to endoscopic procedure | Active comparator | Does not withhold incretin therapy, maintains dose/frequency/duration of medication. Receives: Drug: GLP-1 medication |
| Hold dose prior to endoscopic procedure | No intervention | Withholds prior dose of incretin therapy per ASA guidance recommendations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of RGV (Residual Gastric Volume) in Stomach
Residual gastric volume (RGV) that precludes adequate endoscopic examination
Measured: Procedure
Tracking the Use of Intubation Due to RGV
Measured: Procedure
Aspiration Events Due to RGV (Residual Gastric Volume)
Occurrence of aspiration events requiring extended observation/monitoring, unplanned therapeutics, and/or hospital admission
Measured: Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start31 Jul 2024
- Primary completion20 May 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shah,Tilak, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533527
- Sponsor's protocol ID
- 24-301
- Status last verified
- Nov 2025
- First submitted
- 27 Jun 2024
- Last updated
- 5 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kobori T, Onishi Y, Yoshida Y, Tahara T, Kikuchi T, Kubota T, Iwamoto M, Sawada T, Kobayashi R, Fujiwara H, Kasuga M. Association of glucagon-like peptide-1 receptor agonist treatment with gastric residue in an esophagogastroduodenoscopy. J Diabetes Investig. 2023 Jun;14(6):767-773. doi: 10.1111/jdi.14005. Epub 2023 Mar 15.
PubMed 36919944Silveira SQ, da Silva LM, de Campos Vieira Abib A, de Moura DTH, de Moura EGH, Santos LB, Ho AM, Nersessian RSF, Lima FLM, Silva MV, Mizubuti GB. Relationship between perioperative semaglutide use and residual gastric content: A retrospective analysis of patients undergoing elective upper endoscopy. J Clin Anesth. 2023 Aug;87:111091. doi: 10.1016/j.jclinane.2023.111091. Epub 2023 Mar 2.
PubMed 36870274Joshi G, Abdelmalak B, Weigel W, et al. American Society of Anesthesiologists Consensus-Based Guidance on Preoperative Management of Patients (Adults and Children) on Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists. Released June 29, 2023. Accessed from asahq.org on January 16, 2024.
Ahmad AI, Garg S, Jacobs J, Ansari Z, Al-Din TJ, Almomani A, Valencia S, Vargo J, Chatterjee A, Siddiki H, Hong L, Nicolas MA, Miller A, Shah T. Holding vs Continuing GLP-1/GIP Agonists Before Upper Endoscopy: The OCULUS Randomized Clinical Trial. JAMA Intern Med. 2026 May 1;186(5):578-584. doi: 10.1001/jamainternmed.2026.0027.
PubMed 41837981
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy
- ClinicalTrials.gov ID
- NCT06533527
- Acronym / sponsor ID
- 24-301
- Conditions
- Diabetes Mellitus, Type 2, Obesity, Gastroparesis
- Keywords
- incretin, wegovy, ozempic, mounjaro, glp1, gastroparesis, residual gastric volume, endoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 1 Aug 2024 (actual)
- Results
- Posted 5 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess whether holding incretin-based therapy before endoscopy reduces the likelihood of clinically relevant Residual Gastric Volume (RGV).
Primary Outcomes:
- Residual gastric volume that precludes adequate endoscopic examination
- Residual gastric volume that necessitates premature termination of the endoscopy procedure
- Need for endotracheal intubation due to stomach contents.
- Occurrence of aspiration events requiring extended observation/monitoring, unplanned therapeutics, and/or hospital admission
Secondary Outcomes:
- Presence of any solid food
- Presence of moderate liquid content
- Increased RGV(Residual Gastric Volume) defined as any amount of solid content or > 0.8 mL/Kg of fluid content (measured from the aspiration/suction canister).
- Differences in primary and secondary outcomes between different medications
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continue medication as normal prior to endoscopic procedure | Active comparator | Drug: GLP-1 medicationDoes not withhold incretin therapy, maintains dose/frequency/duration of medication. |
| Hold dose prior to endoscopic procedure | No intervention | –Withholds prior dose of incretin therapy per ASA guidance recommendations. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients using incretin-based therapies at a stable dose for more than 1 month.
- Patients scheduled for outpatient esophagogastroduodenoscopy (EGD), endoscopic ultrasound (EUS), or endoscopic retrograde cholangiopancreatography (ERCP) under monitored anesthesia care.
Key exclusion criteria (5 listed)
- Documented history of gastroparesis (based on a 4-hour solid-phase gastric emptying study)
- Known history of achalasia
- Surgical or genetically altered foregut anatomy
- Known gastric outlet obstruction or pre-procedure imaging suggestive of gastric outlet obstruction.
- Patients who did not follow the standard NPO (nil per oral) instructions.
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 medicationAlso: Tirzepatide, Semaglutide, Liraglutide, DulaglutideContinue taking GLP-1 as normally scheduled prior to endoscopy. | Drug | Continue medication as normal prior to endoscopic procedure |
Primary outcome
Presence of RGV (Residual Gastric Volume) in Stomach
Time frame: Procedure
Residual gastric volume (RGV) that precludes adequate endoscopic examination
Tracking the Use of Intubation Due to RGV
Time frame: Procedure
Aspiration Events Due to RGV (Residual Gastric Volume)
Time frame: Procedure
Occurrence of aspiration events requiring extended observation/monitoring, unplanned therapeutics, and/or hospital admission
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36919944Kobori T, Onishi Y, Yoshida Y, Tahara T, Kikuchi T, Kubota T, Iwamoto M, Sawada T, Kobayashi R, Fujiwara H, Kasuga M. Association of glucagon-like peptide-1 receptor agonist treatment with gastric residue in an esophagogastroduodenoscopy. J Diabetes Investig. 2023 Jun;14(6):767-773. doi: 10.1111/jdi.14005. Epub 2023 Mar 15.
- Results publication: PubMed 36870274Silveira SQ, da Silva LM, de Campos Vieira Abib A, de Moura DTH, de Moura EGH, Santos LB, Ho AM, Nersessian RSF, Lima FLM, Silva MV, Mizubuti GB. Relationship between perioperative semaglutide use and residual gastric content: A retrospective analysis of patients undergoing elective upper endoscopy. J Clin Anesth. 2023 Aug;87:111091. doi: 10.1016/j.jclinane.2023.111091. Epub 2023 Mar 2.
- Results publicationJoshi G, Abdelmalak B, Weigel W, et al. American Society of Anesthesiologists Consensus-Based Guidance on Preoperative Management of Patients (Adults and Children) on Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists. Released June 29, 2023. Accessed from asahq.org on January 16, 2024.
- Derived from this study: PubMed 41837981Ahmad AI, Garg S, Jacobs J, Ansari Z, Al-Din TJ, Almomani A, Valencia S, Vargo J, Chatterjee A, Siddiki H, Hong L, Nicolas MA, Miller A, Shah T. Holding vs Continuing GLP-1/GIP Agonists Before Upper Endoscopy: The OCULUS Randomized Clinical Trial. JAMA Intern Med. 2026 May 1;186(5):578-584. doi: 10.1001/jamainternmed.2026.0027.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GLP-1 medication in people with Diabetes Mellitus, Type 2 and Obesity, run by The Cleveland Clinic at 2 sites in United States.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of RGV (Residual Gastric Volume) in Stomach (time frame: Procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06533527, which also lists 4 linked publications.
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 5 Dec 2025.