What side effects are associated with this type of intervention?

Common treatments for diabetes include insulin, metformin, sulfonylureas, and GLP-1 receptor agonists. Insulin can cause hypoglycemia, weight gain, and injection site reactions. Metformin is often associated with gastrointestinal side effects such as diarrhea, nausea, and abdominal discomfort. Sulfonylureas can lead to hypoglycemia and weight gain. GLP-1 receptor agonists, which may have some relevance to the study of Ondansetron, can cause nausea, vomiting, and diarrhea. These side effects are important considerations when managing diabetes treatment.

What prior FDA approvals exist?

FDA-approved treatments for diabetes primarily include medications that help control blood sugar levels. These include insulin, metformin, sulfonylureas, DPP-4 inhibitors, GLP-1 receptor agonists, and SGLT2 inhibitors. While Ondansetron, a Serotonin 5-HT3 Receptor Antagonist, is being studied for its effects on gastrointestinal symptoms in diabetes, it is not a standard treatment for diabetes itself. The focus of diabetes treatment remains on medications that directly manage blood glucose levels and improve insulin sensitivity.

What other types of research exist?

Promising novel alternatives to Ondansetron for diabetes patients in 2024 may include newer serotonin receptor antagonists, such as palonosetron, which has a longer half-life and potentially fewer side effects. Additionally, emerging treatments like ghrelin receptor agonists and motilin receptor agonists are being investigated for their potential to improve gastrointestinal motility and reduce symptoms. These alternatives are still under clinical evaluation but show promise in early studies.

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5-HT3 Receptor Antagonist

Ondansetron for Indigestion in Diabetics

Phase 2

Recruiting

Led By Adil E Bharucha, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients in the DM group will also require Type 1 or 2 DM of ≥ 3 years duration; in patients with type 2 DM, the dyspepsia symptoms should have begun or worsened after DM was diagnosed

Healthy male or non-pregnant, non-breastfeeding female volunteers

Must not have

Bleeding or clotting disorders or medications that increase risk of bleeding from mucosal biopsies

History of Long QT Syndrome or prolonged QT interval (i.e., corrected QT interval > 480 ms)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, approximately 60-120 minutes

Summary

This trial aims to understand why people with indigestion and diabetes have stomach issues. Researchers will study ondansetron, a medication that prevents nausea, to see its effects on these symptoms. Ondansetron is commonly used to prevent nausea and vomiting, particularly in patients undergoing chemotherapy. The study will look at how ondansetron affects stomach function during different tests and in daily life.

Who is the study for?

This trial is for adults aged 18-75 with diabetes (Type 1 or Type 2) and indigestion symptoms that started or worsened after their diabetes diagnosis. Participants must be able to eat test meals and not be pregnant, breastfeeding, or have a structural cause for symptoms. Those with significant health issues, certain heart conditions, allergies to eggs, or on specific medications are excluded.

What is being tested?

The study tests the effects of Ondansetron (8mg), an anti-nausea medication, against a placebo in managing gastrointestinal discomfort in people with both indigestion and diabetes. It aims to understand if this drug can reduce sensitivity to nutrients causing these symptoms.

What are the potential side effects?

Ondansetron may cause headaches, constipation or diarrhea, dizziness and fatigue. Rarely it can lead to more serious side effects like changes in heartbeat rhythm. The experience of side effects varies from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had diabetes for over 3 years and my stomach discomfort started or got worse after my diagnosis.

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I am a healthy male or a female not pregnant or breastfeeding.

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I have symptoms like feeling full quickly, discomfort after eating, nausea, or vomiting.

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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition or take medication that increases my bleeding risk.

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I have a history of Long QT Syndrome or my heart's QT interval is longer than normal.

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I have poor vein access and no central venous line.

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My tests show positive for TTG antibodies.

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I do not have severe vomiting that would stop me from participating.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in effect of Gastrointestinal symptoms on Quality of Life

Change in severity of daily symptoms

Change in severity of gastrointestinal symptoms

+3 more

Secondary study objectives

C-peptide level

Cholecystokinin (CCK)

Effect of gastrointestinal symptoms on Quality of Life - Nepean Dyspepsia index

+7 more

Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: Non-ulcer dyspepsia (NUD) Ondansetron 8 mgExperimental Treatment1 Intervention

Oral Ondansetron 8 mg administered in a single does dose during gastric emptying and duodenal infusion. Oral Ondansetron 8 mg administered three times a day for weeks 3-6

Group II: Healthy Control Ondansetron 8 mgExperimental Treatment1 Intervention

Oral Ondansetron 8 mg administered in a single does dose during gastric emptying and duodenal infusion.

Group III: Diabetic (DM) gastroenteropathy Ondansetron 8 mgExperimental Treatment1 Intervention

Oral Ondansetron 8 mg administered in a single does dose during gastric emptying and duodenal infusion. Oral Ondansetron 8 mg administered three times a day for weeks 3-6

Group IV: Diabetic (DM) gastroenteropathy PlaceboPlacebo Group1 Intervention

Oral matched placebo administered in a single does dose during gastric emptying and duodenal infusion. Oral matched placebo administered three times a day for weeks 3-6

Group V: Healthy Control PlaceboPlacebo Group1 Intervention

Oral matched placebo administered in a single does dose during gastric emptying and duodenal infusion.

Group VI: Non-ulcer dyspepsia (NUD) PlaceboPlacebo Group1 Intervention

Oral matched placebo administered in a single does dose during gastric emptying and duodenal infusion. Oral matched placebo administered three times a day for weeks 3-6

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ondansetron 8mg

2022

Completed Phase 4

~450

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for diabetes include insulin, which helps cells absorb glucose; metformin, which reduces glucose production in the liver and improves insulin sensitivity; and sulfonylureas, which increase insulin production from the pancreas. These mechanisms are crucial for diabetes patients as they help manage blood glucose levels, preventing complications such as neuropathy, retinopathy, and cardiovascular disease. While Ondansetron, a Serotonin 5-HT3 Receptor Antagonist, is primarily used for gastrointestinal issues, its study in diabetes patients aims to understand its effects on gastrointestinal function, which can be impaired in diabetes, potentially offering new avenues for symptom management.