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

NCT ID: NCT07006142

Last Updated: 2025-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2025-12-30

Brief Summary

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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.

Detailed Description

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The overall objective of this project is to identify a reasonable means by which patients on GLP1-RAs can be safely cared for in the perioperative period that can be agreed upon by all groups involved in perioperative patient care. This will be assessed in patients undergoing upper endoscopy specifically since assessment of gastric contents would be minimally invasive for this patient population receiving anesthetic care.

Conditions

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Upper Endoscopy GLP1-R-related Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This study has 3 arms, but two of them are historical cohorts (i.e. previous patients who have already been taken care of). One group will consist of patients who are not on GLP1 medications who underwent upper endoscopy, and another group will consist of patients who are on GLP1 medications who underwent upper endoscopy. The third group is the prospective group who are being enrolled and recruited - this group will consist of patients who are on GLP1 medications who abide by a modified fasting guideline consisting of a full-liquid diet 48 hours prior to procedure, clear liquid diet 24 hours prior to procedure, and no liquids or solids after midnight on the day of upper endoscopy.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Normal fasting guidelines and not taking GLP1-RAs

Patients who are not taking GLP1 RAs (Receptor Agonists) and who will abide by the normal fasting guidelines

Group Type NO_INTERVENTION

No interventions assigned to this group

Normal fasting guidelines with GLP1-RAs

Patients who are taking GLP1 RAs (Receptor Agonists) for either diabetes or weight loss management who will abide by normal fasting guidelines

Group Type NO_INTERVENTION

No interventions assigned to this group

Modified fasting guidelines with GLP1-RAs

Patients who are prescribed and taking GLP1 RAs (Receptor Agonists) for either diabetes or weight loss management who follow the modified fasting guidelines. Modified fasting consists of a full-liquid diet 48 hours prior to the procedures, clear liquid diet 24 hours prior to their procedure, and nothing by mouth (NPO) after midnight on the day of their procedure.

Group Type EXPERIMENTAL

Modified Fasting Guidelines

Intervention Type OTHER

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

Interventions

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Modified Fasting Guidelines

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing elective upper endoscopy with gastroenterology team

Exclusion Criteria

* 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
* Achalasia
* Pancreatitis
* Use of outpatient pro-motility medications
* Patient refusal
* Inability for patient to provide own consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Krishnan Ramanujan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Krishnan Ramanujan, MD

Role: CONTACT

507-422-4898

Facility Contacts

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Krishnan Ramanujan, MD

Role: primary

507-422-4898

Other Identifiers

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23-013192

Identifier Type: -

Identifier Source: org_study_id

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