Modified Fasting Guidelines for Diabetes

Overseen By Krishnan Ramanujan, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must be taking: GLP1-RAs

Must not be taking: Pro-motility medications

Disqualifiers: Urgent procedure, Gastroparesis, others

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

Compensation: Varies

Number of Visits: 2

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a modified fasting plan can lower the risk of aspiration (breathing in food or liquid into the airways) for people taking GLP1-RAs, medications often used for diabetes or weight loss. Participants will either follow this new fasting plan, which involves a liquid diet before their procedure, or adhere to regular fasting guidelines. The trial targets individuals scheduled for a routine upper endoscopy (a procedure to examine the upper digestive system). It excludes those with certain digestive conditions, such as gastroparesis (slowed stomach emptying), or those requiring urgent procedures. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance safety guidelines for medical procedures.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those using outpatient pro-motility medications. It's best to discuss your specific medications with the trial team.

What prior data suggests that this modified fasting protocol is safe for patients on GLP1-RAs?

Research has shown that medications called GLP-1 receptor agonists, often used for diabetes and weight management, can cause side effects such as nausea, vomiting, and dizziness. These side effects are usually mild and resolve on their own, though rare cases of more serious issues have occurred.

In this study, participants follow a special diet before procedures: only liquid foods 48 hours prior, clear liquids 24 hours prior, and no food or drink after midnight on the day of the procedure. While specific data on the safety of these exact guidelines is lacking, such fasting plans are generally considered safe.

Overall, using GLP-1 receptor agonists along with this special diet appears to be well-tolerated, with most side effects being mild. However, consulting a healthcare professional is advisable if there are any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the modified fasting guidelines for diabetes because they offer a new approach to managing pre-procedure fasting, especially for patients on GLP1 receptor agonists. Traditional fasting methods can be challenging for people with diabetes, potentially impacting blood sugar levels. These modified guidelines include a full-liquid diet 48 hours before a procedure and a clear liquid diet 24 hours prior, which might help in maintaining better blood sugar control. This innovative approach could lead to safer and more comfortable experiences for patients, potentially improving outcomes during medical procedures.

What evidence suggests that the modified fasting guidelines could be effective for reducing aspiration risk in patients on GLP1-RAs?

This trial will compare modified fasting guidelines with normal fasting guidelines for patients with diabetes. Research has shown that combining lifestyle changes with GLP-1 receptor agonists, a medication for diabetes and weight loss, leads to noticeable weight loss. Participants in this trial may take GLP-1 receptor agonists. Studies have found that these medications often improve cholesterol and fat levels in the blood, which are important for heart health. GLP-1 receptor agonists also aid in weight management, making it easier to lose weight and maintain it. Some people may experience stomach-related side effects, but these are usually manageable. Overall, using this medication along with lifestyle changes appears promising for improving health outcomes. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for patients scheduled for elective upper endoscopy who are taking GLP1 receptor agonists, a diabetes medication. It's not open to those who refuse participation, have had certain other GI procedures recently, take pro-motility drugs, need urgent care, or can't consent on their own.

Inclusion Criteria

I am scheduled for an upper endoscopy with the gastroenterology team.

Exclusion Criteria

I have chosen not to participate in certain treatments or procedures.

My upcoming procedure includes a colonoscopy or small bowel examination.

Upper GI barium study performed in past 24 hours

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-procedure Fasting

Participants follow modified or normal fasting guidelines prior to upper endoscopy

48 hours

1 visit (in-person)

Procedure

Participants undergo upper endoscopy to assess gastric contents

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure, including diagnosis of aspiration and ICU admission

72 hours

What Are the Treatments Tested in This Trial?

Interventions

• Modified Fasting Guidelines

Trial Overview The study is testing if changing the fasting guidelines before an endoscopy can lower the risk of aspiration in patients using GLP1-RAs. Aspiration happens when stomach contents enter the lungs during or after anesthesia.

How Is the Trial Designed?

Group I: Modified fasting guidelines with GLP1-RAs Experimental Treatment 1 Intervention

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 II: Normal fasting guidelines and not taking GLP1-RAs Active Control 1 Intervention

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

Group III: Normal fasting guidelines with GLP1-RAs Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12414836/

Efficacy of lifestyle modification combined with GLP-1 receptor ... By pooling data from 33 studies, we demonstrated that lifestyle modification combined with GLP-1RAs result in a significant mean weight loss ...

2. diabetesjournals.org diabetesjournals.org/diabetes/article/73/10/1605/156952/GLP-1-Receptor-Agonist-Treatment-Improves-Fasting

GLP-1 Receptor Agonist Treatment Improves Fasting and ... In conclusion, 3-month exenatide treatment had a beneficial effect on both the fasting and postprandial lipidomic profile, blunting the rise in ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2667368124000299

Weight loss outcomes, tolerability, side effects, and risks GLP-1RAs are effective in managing obesity, their use is associated with gastrointestinal side effects and rare but serious adverse events.

4. ahajournals.org ahajournals.org/doi/10.1161/JAHA.122.029282

Role of Glucagon‐Like Peptide‐1 Receptor Agonists in ... GLP‐1 RAs have also been shown to be effective for weight management and maintenance of weight loss in the treatment of people with overweight ...

5. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK551568/

Glucagon-Like Peptide-1 Receptor Agonists - StatPearls - NCBI Patients have shown improved satisfaction with weekly exenatide compared to a twice-daily regimen, and studies have demonstrated their ...

6. nature.com nature.com/articles/s41598-025-99622-4

Efficacy and safety of GLP-1 receptor agonists on weight ... GLP-1RAs effectively reduced body weight, BMI and insulin resistance in patients with PCOS, although they were accompanied by nausea, vomiting and dizziness.

7. dmsjournal.biomedcentral.com dmsjournal.biomedcentral.com/articles/10.1186/s13098-024-01371-3

Efficacy and safety of glucagon-like peptide-1 receptor ... GLP-1 receptor agonists have been shown to improve glycemic control, decrease body weight, and cardiometabolic parameters [16,17,18], improve ...