Trials Today

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

Purpose

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.

Conditions

Upper Endoscopy
GLP1-R-related Disease

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: N/A
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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 Purpose: Prevention
Masking: Single (Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
No Intervention 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
No Intervention 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
Experimental 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.	Other: 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

Recruiting Locations

Mayo Clinic in Rochester
Rochester, Minnesota 55905

Contact:
Krishnan Ramanujan, MD
507-422-4898
ramanujan.krishnan@mayo.edu

More Details

NCT ID: NCT07006142
Status: Recruiting
Sponsor: Mayo Clinic

Study Contact

Krishnan Ramanujan, MD
507-422-4898
ramanujan.krishnan@mayo.edu

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.