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

No Placebo-Only Group

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

Select...

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.

Select...

I have had surgery on or genetic changes to my upper digestive tract.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ procedure

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