A Phase 4 interventional study of GLP-1 medication in Diabetes Mellitus, Type 2, Obesity and Gastroparesis, sponsored by The Cleveland Clinic. Completed at 2 sites in United States. Per ClinicalTrials.gov, last updated 2025-12-05.
Sponsored by The Cleveland Clinic · Phase 4, Interventional, and Health services research
To assess whether holding incretin-based therapy before endoscopy reduces the likelihood of clinically relevant Residual Gastric Volume (RGV).
Primary Outcomes:
Secondary Outcomes:
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 69 is below the median of 80 across 7,523 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.
Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Does not withhold incretin therapy, maintains dose/frequency/duration of medication.
Drug: GLP-1 medication
Withholds prior dose of incretin therapy per ASA guidance recommendations.
Continue taking GLP-1 as normally scheduled prior to endoscopy.
Also known as: Tirzepatide, Semaglutide, Liraglutide, Dulaglutide
Presence of RGV (Residual Gastric Volume) in Stomach
Residual gastric volume (RGV) that precludes adequate endoscopic examination
Time frame: Procedure
Tracking the Use of Intubation Due to RGV
Time frame: Procedure
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
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.
| 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 |
Residual gastric volume (RGV) that precludes adequate endoscopic examination
| Participants | Continue medication as normal prior to endoscopic procedure | Hold dose prior to endoscopic procedure |
|---|---|---|
| Presence of RGV (Residual Gastric Volume) in Stomach | 7 | 1 |
| Participants | Continue medication as normal prior to endoscopic procedure | Hold dose prior to endoscopic procedure |
|---|---|---|
| Tracking the Use of Intubation Due to RGV | 0 | 0 |
Occurrence of aspiration events requiring extended observation/monitoring, unplanned therapeutics, and/or hospital admission
| number of aspiration events | Continue medication as normal prior to endoscopic procedure | Hold dose prior to endoscopic procedure |
|---|---|---|
| Aspiration Events Due to RGV (Residual Gastric Volume) | 0 | 0 |
Collected over Adverse events collected from the time of the endoscopy procedure up to one week after the procedure.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Continue medication as normal prior to endoscopic procedure | 0/28 (0%) | 0/28 (0%) | 0/28 (0%) |
| Hold dose prior to endoscopic procedure | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
Nine patients met exclusion criteria and not included in analysis
| Age, Continuous(years) | Continue Medication as Normal Prior to Endoscopic Procedure | Hold Dose Prior to Endoscopic Procedure | Total |
|---|---|---|---|
| Median | 62.5 (30 to 87) | 62.5 (39 to 78) | 62.5 (30 to 87) |
| Sex: Female, Male(Participants) | Continue Medication as Normal Prior to Endoscopic Procedure | Hold Dose Prior to Endoscopic Procedure | Total |
|---|---|---|---|
| Female | 15 | 15 | 30 |
| Male | 13 | 17 | 30 |
| Race and Ethnicity Not Collected(Participants) | Continue Medication as Normal Prior to Endoscopic Procedure | Hold Dose Prior to Endoscopic Procedure | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Diabetes(Participants) | Continue Medication as Normal Prior to Endoscopic Procedure | Hold Dose Prior to Endoscopic Procedure | Total |
|---|---|---|---|
| Count of participants | 7 | 10 | 17 |
| A1c greater than 7(Participants) | Continue Medication as Normal Prior to Endoscopic Procedure | Hold Dose Prior to Endoscopic Procedure | Total |
|---|---|---|---|
| Count of participants | 7 | 6 | 13 |
| A1c(Percent of glycated hemoglobin) | Continue Medication as Normal Prior to Endoscopic Procedure | Hold Dose Prior to Endoscopic Procedure | Total |
|---|---|---|---|
| Median | 6.4 (5 to 10.6) | 6.4 (4.8 to 9.2) | 6.4 (4.8 to 10.6) |
| BMI(kg/m^2) | Continue Medication as Normal Prior to Endoscopic Procedure | Hold Dose Prior to Endoscopic Procedure | Total |
|---|---|---|---|
| Median | 31.0 (20.2 to 40.9) | 29.7 (23.6 to 49.9) | 30 (20.2 to 49.9) |
| Drug type(Participants) | Continue Medication as Normal Prior to Endoscopic Procedure | Hold Dose Prior to Endoscopic Procedure | Total |
|---|---|---|---|
| Dulaglutide | 3 | 4 | 7 |
| Semaglutide | 10 | 20 | 30 |
| Tirzepatide | 15 | 8 | 23 |
3 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The Cleveland Clinic