Assessing the impact of stopping incretin therapies before endoscopy
Randomized Trial of Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy
This study is testing if stopping certain diabetes medications before an upper endoscopy can help people with Type 2 Diabetes, obesity, and gastroparesis have a safer procedure by reducing stomach contents.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 2 sites (Weston, Florida and 1 other locations) |
| Trial ID | NCT06533527 on ClinicalTrials.gov |
What this trial studies
This study evaluates whether pausing incretin-based therapies prior to upper endoscopy can lower the risk of clinically significant Residual Gastric Volume (RGV). It focuses on patients with Type 2 Diabetes, obesity, and gastroparesis who are scheduled for procedures like EGD, EUS, or ERCP. The primary outcomes include measuring RGV that could hinder endoscopic examination and the need for intubation due to stomach contents. Secondary outcomes will assess the presence of solid food and liquid content in the stomach.
Who should consider this trial
Good fit: Ideal candidates are patients on stable incretin-based therapies for over a month who are scheduled for outpatient endoscopic procedures.
Not a fit: Patients with a history of gastroparesis, achalasia, or other significant gastric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the safety and effectiveness of endoscopic procedures for patients on incretin therapies.
How similar studies have performed: While the approach of managing incretin therapy before endoscopy is relatively novel, similar studies have shown that optimizing gastric conditions can enhance procedural outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Weston, Florida and 1 other locations
- Cleveland Clinic — Weston, Florida, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Tilak Shah, MD
- Email: shaht3@ccf.org
- Phone: 877.463.2010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.