Clear Liquid Diet for Reducing Pulmonary Aspiration Risk

Overseen By Paul Potnuru

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Must be taking: GLP-1 RAs

Must not be taking: Erythromycin, Metoclopramide, Domperidone, Opioids

Disqualifiers: Gastric resection, Pregnant, Trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

136 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking erythromycin, metoclopramide, domperidone, or opioids.

What data supports the effectiveness of the drug GLP-1 RA for reducing pulmonary aspiration risk?

GLP-1 RAs are known to delay gastric emptying, which might help reduce the risk of pulmonary aspiration (inhaling food or liquid into the lungs) by keeping the stomach contents from moving too quickly into the intestines. ^{1 2 3 4 5}

Is a clear liquid diet safe for reducing pulmonary aspiration risk?

The research on water protocols for patients with swallowing difficulties showed that participants did not experience any harmful effects, like pneumonia, during the trial. This suggests that clear liquid diets, when carefully managed, can be safe for reducing aspiration risk. ^{6 7 8 9 10}

How does a clear liquid diet reduce pulmonary aspiration risk compared to other treatments?

The clear liquid diet is unique because it involves consuming only transparent liquids, which are less likely to cause aspiration (inhaling food or liquid into the lungs) compared to solid foods. This approach is different from drug-based treatments as it focuses on dietary modification to minimize the risk of aspiration. ^{1 4 11 12 13}

What is the purpose of this trial?

The purpose of this study is to determine if prolonged fasting from solids and transitioning to a CLD for 24 hours is protective to decrease RGC in patients on GLP-1 RAs presenting for upper endoscopy, to determine if prolonged fasting is associated with increased thirst, hunger and anxiety, To determine if signs and symptoms of nausea, vomiting, retching, abdominal bloating, and abdominal pain are present on the day of surgery, to see if there is any variability between preoperative gastric ultrasound assessment and volume of gastric contents visualized on upper endoscopy, to determine time of gastric emptying by serial Gastric ultrasonography (GUS) scans every 2 hours in subjects who presented with an initial at-risk scan, to determine the choice of anesthesia used based on preoperative GUS results, to determine if there were any adverse events recorded in this study group, to determine if duration of GLP-1 RA therapy has an association with residual gastric content (RGC). and to determine if dosing of GLP-1 RA has an association with RGC.

Research Team

Sudipta Sen, MD, FASA

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

This trial is for patients on GLP-1 receptor agonists who are scheduled for upper endoscopy. They're looking at whether a clear liquid diet (CLD) for 24 hours before the procedure can help reduce stomach contents and improve safety during anesthesia.

Inclusion Criteria

I am currently taking GLP-1 receptor agonists.

I am scheduled for an upper endoscopy without a colonoscopy.

Exclusion Criteria

Gastric band in situ

Recent trauma

I have a history of delayed stomach emptying.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-procedure Preparation

Participants undergo prolonged fasting from solids and transition to a clear liquid diet for 24 hours to decrease residual gastric content

24 hours

Procedure and Assessment

Participants undergo upper endoscopy and preoperative gastric ultrasound assessment to evaluate residual gastric content and determine anesthesia choice

1 day

1 visit (in-person)

Follow-up

Participants are monitored for adverse events and symptoms such as nausea, vomiting, and abdominal pain post-procedure

1-2 weeks

Treatment Details

Interventions

• GLP-1 RA

Trial Overview The study tests if a clear liquid diet versus standard fasting protocols can lower residual gastric content in patients taking GLP-1 RA medications before receiving anesthesia. It also examines patient comfort, timing of gastric emptying, choice of anesthesia, and any adverse events.

Participant Groups

Group I: GLP-1 RA users with prolonged fasting instructions Experimental Treatment 1 Intervention

Group II: GLP-1 RA users with standard NPO instructions Active Control 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Findings from Research

Patients with cystic fibrosis (CF) and cystic fibrosis-related diabetes (CFRD) have significantly lower levels of active GLP-1 compared to healthy controls, which may impact their insulin regulation and diabetes progression.

The study suggests that the inactive form of GLP-1 is more prevalent in CF patients, indicating a potential area for further research into GLP-1 analogues as a treatment option for improving metabolic health in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced levels of active GLP-1 in patients with cystic fibrosis with and without diabetes mellitus. Hillman, M., Eriksson, L., Mared, L., et al.[2012]

References

1. United States pubmed.ncbi.nlm.nih.gov

Use of Glucagon-Like-Peptide 1 Receptor Agonists and Risk of Fracture as Compared to Use of Other Anti-hyperglycemic Drugs. [2018]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Liraglutide Inhibits Osteoclastogenesis and Improves Bone Loss by Downregulating Trem2 in Female Type 1 Diabetic Mice: Findings From Transcriptomics. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Gastrointestinal adverse events with insulin glargine/lixisenatide fixed-ratio combination versus glucagon-like peptide-1 receptor agonists in people with type 2 diabetes mellitus: A network meta-analysis. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Endogenous glucagon-like peptide 1 controls endocrine pancreatic secretion and antro-pyloro-duodenal motility in humans. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Effects of efpeglenatide versus liraglutide on gastric emptying, glucose metabolism and beta-cell function in people with type 2 diabetes: an exploratory, randomized phase Ib study. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Effect of postpyloric feeding on gastroesophageal regurgitation and pulmonary microaspiration: results of a randomized controlled trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Interventions to Prevent Aspiration Pneumonia in Older Adults: An Updated Systematic Review. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Outcomes of a pilot water protocol project in a rehabilitation setting. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Chronic pulmonary aspiration in children. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Inflammatory Effects of Thickened Water on the Lungs in a Murine Model of Recurrent Aspiration. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Glucagon-Like Peptide 1 Receptor Agonists and Chronic Lower Respiratory Disease Exacerbations Among Patients With Type 2 Diabetes. [2022]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Reduced levels of active GLP-1 in patients with cystic fibrosis with and without diabetes mellitus. [2012]

13. England pubmed.ncbi.nlm.nih.gov

Glucagon-like peptide-1 response to whey protein is less diminished by dipeptidyl peptidase-4 in comparison with responses to dextrin, a lipid and casein in rats. [2021]