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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 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

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.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,350 Previous Clinical Trials
3,060,524 Total Patients Enrolled
23 Trials studying Diabetes
6,750 Patients Enrolled for Diabetes
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,455 Previous Clinical Trials
4,334,965 Total Patients Enrolled
109 Trials studying Diabetes
138,677 Patients Enrolled for Diabetes
Adil E Bharucha, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
160 Total Patients Enrolled

Media Library

Ondansetron (5-HT3 Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT03865290 — Phase 2
Diabetes Research Study Groups: Diabetic (DM) gastroenteropathy Placebo, Healthy Control Placebo, Non-ulcer dyspepsia (NUD) Placebo, Healthy Control Ondansetron 8 mg, Non-ulcer dyspepsia (NUD) Ondansetron 8 mg, Diabetic (DM) gastroenteropathy Ondansetron 8 mg
Diabetes Clinical Trial 2023: Ondansetron Highlights & Side Effects. Trial Name: NCT03865290 — Phase 2
Ondansetron (5-HT3 Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03865290 — Phase 2
~4 spots leftby Mar 2025