Randomized Trial of Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy
| Registry | NCT06533527 |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: double, health services research |
| Enrollment | 69 (Actual) |
| Sponsor | The Cleveland Clinic (Other) |
| Conditions | Diabetes Mellitus, Type 2, Obesity, Gastroparesis |
| Interventions | GLP-1 medication (Drug) |
| Dates | start 2024-07-31, primary completion 2025-05-20, completion 2025-05-20, first posted 2024-08-01, last updated 2025-12-05 |
| Locations | 2 sites in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Diabetes Mellitus, Type 2 All trials for Obesity All trials of GLP-1 medication
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Continue medication as normal prior to endoscopic procedure | Active comparator | Drug: GLP-1 medication | Does 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. |
Sex: All, accepts healthy volunteers
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
| Milestone | Continue medication as normal prior to endoscopic procedure | Hold dose prior to endoscopic procedure |
|---|---|---|
| Started | 28 | 32 |
| Completed | 28 | 32 |
| Not completed | 0 | 0 |
Time frame: Adverse events collected from the time of the endoscopy procedure up to one week after the procedure.
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Continue medication as normal prior to endoscopic procedure | 0/28 (0.0%) | 0/28 (0.0%) | 0/28 (0.0%) |
| Hold dose prior to endoscopic procedure | 0/32 (0.0%) | 0/32 (0.0%) | 0/32 (0.0%) |
| Facility | City | Country | Status |
|---|---|---|---|
| Cleveland Clinic | Weston, Florida | United States | |
| Cleveland Clinic | Cleveland, Ohio | United States |