Upper EndoscopyNCT07006142
Effect of Prolonged Fasting Time on Gastric Residual Volume in Patients Taking GLP1 Receptor Agonists
A study testing Modified Fasting Guidelines in people with Upper Endoscopy and GLP1-R-related Disease, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Endoscopy, GLP1-R-related Disease
- What is being tested?
- Modified Fasting Guidelines
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective upper endoscopy with gastroenterology team
Who cannot join
- 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
Show all 9Show fewer
- Use of outpatient pro-motility medications
- Patient refusal
- Inability for patient to provide own consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Krishnan Ramanujan, MD, 507-422-4898, ramanujan.krishnan@mayo.edu
About this study
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.
Read the 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.
- Conditions
- Upper Endoscopy, GLP1-R-related Disease
- Being tested
- Modified Fasting Guidelines
- Keywords
- GLP1 receptor agonists, upper endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Fasting GuidelinesOther
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
| Study group | Role | What they receive |
|---|---|---|
| Normal fasting guidelines and not taking GLP1-RAs | No intervention | Patients who are not taking GLP1 RAs (Receptor Agonists) and who will abide by the normal fasting guidelines |
| Normal fasting guidelines with GLP1-RAs | No intervention | Patients who are taking GLP1 RAs (Receptor Agonists) for either diabetes or weight loss management who will abide by normal fasting guidelines |
| Modified fasting guidelines with GLP1-RAs | Experimental | 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. Receives: Other: Modified Fasting Guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric contents
Number of patients who were found to have gastric contents within the stomach during the upper endoscopy.
Measured: Baseline
Secondary outcomes (3)
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.
Measured: From the time of upper endoscopy until 72 hours post-procedure.
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.
Measured: 72 hours after completion of upper endoscopy
Postprocedural ICU admission
The number of patients who were admitted to the ICU immediately after upper endoscopy.
Measured: Immediately after upper endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start1 Aug 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper EndoscopyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krishnan Ramanujan, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006142
- Sponsor's protocol ID
- 23-013192
- Status last verified
- Sep 2026
- First submitted
- 27 May 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prolonged Fasting Time on Gastric Residual Volume in Patients Taking GLP1 Receptor Agonists
- ClinicalTrials.gov ID
- NCT07006142
- Acronym / sponsor ID
- 23-013192
- Conditions
- Upper Endoscopy, GLP1-R-related Disease
- Keywords
- GLP1 receptor agonists, upper endoscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Normal fasting guidelines and not taking GLP1-RAs | No intervention | –Patients who are not taking GLP1 RAs (Receptor Agonists) and who will abide by the normal fasting guidelines |
| Normal fasting guidelines with GLP1-RAs | No intervention | –Patients who are taking GLP1 RAs (Receptor Agonists) for either diabetes or weight loss management who will abide by normal fasting guidelines |
| Modified fasting guidelines with GLP1-RAs | Experimental | Other: Modified Fasting GuidelinesPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing elective upper endoscopy with gastroenterology team
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Fasting GuidelinesPatients 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 | Other | Modified fasting guidelines with GLP1-RAs |
Primary outcome
Gastric contents
Time frame: Baseline
Number of patients who were found to have gastric contents within the stomach during the upper endoscopy.
3 secondary outcomes
Diagnosis of aspiration within 72 hours of procedure
Time frame: From the time of upper endoscopy until 72 hours post-procedure.
Aspiration pneumonitis diagnosis postoperatively
Time frame: 72 hours after completion of upper endoscopy
Postprocedural ICU admission
Time frame: Immediately after upper endoscopy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Fasting Guidelines in people with Upper Endoscopy and GLP1-R-related Disease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Krishnan Ramanujan, MD (507-422-4898, ramanujan.krishnan@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric contents (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.