Diabetes Mellitus, Type 2, Gastroparesis, Obesity
Conditions
Keywords
incretin, wegovy, ozempic, mounjaro, glp1, gastroparesis, residual gastric volume, endoscopy, anesthesia
Brief 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 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
Interventions
DRUGGLP-1 medication
Continue taking GLP-1 as normally scheduled prior to endoscopy.
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of RGV (Residual Gastric Volume) in Stomach | Procedure | Residual gastric volume (RGV) that precludes adequate endoscopic examination |
| Tracking the Use of Intubation Due to RGV | Procedure | — |
| Aspiration Events Due to RGV (Residual Gastric Volume) | Procedure | Occurrence of aspiration events requiring extended observation/monitoring, unplanned therapeutics, and/or hospital admission |
Countries
United States
Participant flow
Recruitment details
Adults 18 or older who were scheduled to undergo an upper endoscopic procedure under monitored anesthesia care or moderate sedation were recruited from Cleveland Clinic hospital main campus or Cleveland Clinic Weston. Patients undergoing colonoscopy were permitted to participate if they were also undergoing an upper endoscopic procedure concurrently. Recruitment occurred from July 2024 until May 2025.
Pre-assignment details
One patient was excluded prior to assignment due to having stop the GLP medication prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| Continue Medication as Normal Prior to Endoscopic Procedure Does not withhold incretin therapy, maintains dose/frequency/duration of medication. | 28 |
| Hold Dose Prior to Endoscopic Procedure Withholds prior dose of incretin therapy per ASA guidance recommendations. | 32 |
| Total | 60 |
Baseline characteristics
| Characteristic | Total | Hold Dose Prior to Endoscopic Procedure | Continue Medication as Normal Prior to Endoscopic Procedure |
|---|---|---|---|
| A1c | 6.4 Percent of glycated hemoglobin | 6.4 Percent of glycated hemoglobin | 6.4 Percent of glycated hemoglobin |
| A1c greater than 7 | 13 Participants | 6 Participants | 7 Participants |
| Age, Continuous | 62.5 years | 62.5 years | 62.5 years |
| BMI | 30 kg/m^2 | 29.7 kg/m^2 | 31.0 kg/m^2 |
| Diabetes | 17 Participants | 10 Participants | 7 Participants |
| Drug type Dulaglutide | 7 Participants | 4 Participants | 3 Participants |
| Drug type Semaglutide | 30 Participants | 20 Participants | 10 Participants |
| Drug type Tirzepatide | 23 Participants | 8 Participants | 15 Participants |
| Duration on drug | 5.8 months | 5.5 months | 6.0 months |
| Indications for the Procedure Anemia | 1 Participants | 0 Participants | 1 Participants |
| Indications for the Procedure Disease follow-up | 20 Participants | 12 Participants | 8 Participants |
| Indications for the Procedure Dyspepsia | 5 Participants | 2 Participants | 3 Participants |
| Indications for the Procedure Heartburn | 8 Participants | 5 Participants | 3 Participants |
| Indications for the Procedure Others | 23 Participants | 13 Participants | 10 Participants |
| Preprocedural symptoms Bloating | 3 Participants | 1 Participants | 2 Participants |
| Preprocedural symptoms Dyspepsia | 2 Participants | 1 Participants | 1 Participants |
| Preprocedural symptoms Heartburn | 1 Participants | 0 Participants | 1 Participants |
| Preprocedural symptoms Nausea | 1 Participants | 0 Participants | 1 Participants |
| Preprocedural symptoms No symptoms reported | 31 Participants | 18 Participants | 13 Participants |
| Preprocedural symptoms Other Symptoms | 21 Participants | 12 Participants | 9 Participants |
| Preprocedural symptoms Vomiting | 1 Participants | 0 Participants | 1 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Sex: Female, Male Female | 30 Participants | 15 Participants | 15 Participants |
| Sex: Female, Male Male | 30 Participants | 17 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 32 |
| other Total, other adverse events | 0 / 28 | 0 / 32 |
| serious Total, serious adverse events | 0 / 28 | 0 / 32 |
Outcome results
Primary
Aspiration Events Due to RGV (Residual Gastric Volume)
Occurrence of aspiration events requiring extended observation/monitoring, unplanned therapeutics, and/or hospital admission
Time frame: Procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Continue medication as normal prior to endoscopic procedure | Aspiration Events Due to RGV (Residual Gastric Volume) | 0 number of aspiration events |
| Hold dose prior to endoscopic procedure | Aspiration Events Due to RGV (Residual Gastric Volume) | 0 number of aspiration events |
Primary
Presence of RGV (Residual Gastric Volume) in Stomach
Residual gastric volume (RGV) that precludes adequate endoscopic examination
Time frame: Procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continue medication as normal prior to endoscopic procedure | Presence of RGV (Residual Gastric Volume) in Stomach | 7 Participants |
| Hold dose prior to endoscopic procedure | Presence of RGV (Residual Gastric Volume) in Stomach | 1 Participants |
Primary
Tracking the Use of Intubation Due to RGV
Time frame: Procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continue medication as normal prior to endoscopic procedure | Tracking the Use of Intubation Due to RGV | 0 Participants |
| Hold dose prior to endoscopic procedure | Tracking the Use of Intubation Due to RGV | 0 Participants |