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Effect of Prolonged Fasting Time on Gastric Residual Volume in Patients Taking GLP1 Receptor Agonists

ConditionsUpper EndoscopyGLP1-R-related Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

The aim of this study is to determine whether a modified fasting protocol can reduce the potential risk of aspiration for patients currently prescribed GLP1-RAs.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing elective upper endoscopy with gastroenterology team

Disqualifiers

Urgent or emergent procedure

Inclusion of colonoscopy or antegrade small bowel enteroscopy in planned procedure

Upper GI barium study performed in past 24 hours.

Gastroparesis

Trial design

Design model

Single group

Treatments tested in this trial

  • Modified Fasting Guidelines

    Other intervention

    Patients will follow a full-liquid diet 48 hours prior to their procedure, clear liquid diet 24 hours prior to their procedure, and nothing by mouth (NPO) after midnight on the day of their procedure

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Normal fasting guidelines and not taking GLP1-RAsNo intervention 0 interventions
Group B: Normal fasting guidelines with GLP1-RAsNo intervention 0 interventions
Group C: Modified fasting guidelines with GLP1-RAsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Gastric contents

Number of patients who were found to have gastric contents within the stomach during the upper endoscopy.

Time frame
Baseline

Secondary outcomes

1

Diagnosis of aspiration within 72 hours of procedure

Whether or not a patient was diagnosed with aspiration will be determined via chart review for 72 hours after the completion of upper endoscopy. A note documenting aspiration or an ICD code associated with aspiration will indicate that this outcome occurred.

Time frame
From the time of upper endoscopy until 72 hours post-procedure.
2

Aspiration pneumonitis diagnosis postoperatively

The number of patients who have a diagnosis of aspiration pneumonitis, as identified by the presence of ICD codes J69.0 or J69.8, postoperatively.

Time frame
72 hours after completion of upper endoscopy
3

Postprocedural ICU admission

The number of patients who were admitted to the ICU immediately after upper endoscopy.

Time frame
Immediately after upper endoscopy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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