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Incretin Mimetic

Holding vs. Continuing Incretin-Based Therapies for Type 2 Diabetes

N/A
Recruiting
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients scheduled for outpatient esophagogastroduodenoscopy (EGD), endoscopic ultrasound (EUS), or endoscopic retrograde cholangiopancreatography (ERCP) under monitored anesthesia care
Must not have
Known history of achalasia
Surgical or genetically altered foregut anatomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up procedure
Awards & highlights

Summary

This trial aims to see if stopping incretin-based therapy before endoscopy can reduce the chances of having too much food in the stomach. The main things they are looking at are: - The

Who is the study for?
This trial is for individuals with Type 2 Diabetes, Gastroparesis, and Obesity who are undergoing an upper endoscopy. Participants must be on incretin-based therapies like Dulaglutide, Semaglutide, Tirzepatide or Liraglutide.
What is being tested?
The study aims to determine if stopping incretin-based medications before an upper endoscopy can reduce the risk of complications by decreasing residual gastric volume (RGV), which might interfere with the procedure.
What are the potential side effects?
While specific side effects aren't listed here, incretin-based therapies generally may cause gastrointestinal symptoms such as nausea or vomiting, potential pancreatitis risk and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for a specific stomach or digestive tract examination under anesthesia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with achalasia.
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I have had surgery on or genetic changes to my upper digestive tract.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Need for endotracheal intubation due to stomach contents.
Occurrence of aspiration events requiring extended observation/monitoring, unplanned therapeutics, and/or hospital admission
Residual gastric volume(RGV) that necessitates premature termination of the endoscopy procedure
+1 more
Secondary study objectives
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).
Presence of any solid food
Presence of moderate liquid content
+1 more

Trial Design

2Treatment groups
Active Control
Group I: Continue medication as normal prior to endoscopic procedureActive Control4 Interventions
Does not withhold incretin therapy, maintains dose/frequency/duration of medication.
Group II: Hold dose prior to endoscopic procedureActive Control1 Intervention
Withholds prior dose of incretin therapy per ASA guidance recommendations.

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,045 Previous Clinical Trials
1,370,555 Total Patients Enrolled
2 Trials studying Gastroparesis
140 Patients Enrolled for Gastroparesis
~80 spots leftby Jul 2025
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