Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT03865290

Effects of Ondansetron on Gastrointestinal Sensorimotor Dysfunctions in Diabetes Mellitus and Dyspepsia

Led by Mayo Clinic · Updated on 2026-05-04

150

Participants Needed

1

Research Sites

465 weeks

Total Duration

On this page

Sponsors

M

Mayo Clinic

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are trying to understand why people with indigestion and diabetes mellitus have gastrointestinal symptoms and in particular to understand whether symptoms are related to increased sensitivity to nutrients in the small intestine. As part of this investigation, a medication called ondansetron will also be studied to determine its effects on gastrointestinal function and associated symptoms.

CONDITIONS

Official Title

Effects of Ondansetron on Gastrointestinal Sensorimotor Dysfunctions in Diabetes Mellitus and Dyspepsia

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy male or non-pregnant, non-breastfeeding female volunteers
  • Age between 18 and 75 years
  • Able to provide written informed consent
  • Able to communicate well and comply with all study requirements including willingness to consume test meal components
  • Symptoms of dyspepsia like early satiety, post-meal discomfort, nausea, vomiting, or regurgitation
  • For diabetes group: Type 1 or 2 diabetes mellitus for 3 or more years; in type 2, dyspepsia symptoms began or worsened after diabetes diagnosis
Not Eligible

You will not qualify if you...

  • History of major abdominal surgery except appendectomy, cholecystectomy, tubal ligation, hysterectomy, herniorrhaphy, or limited colon resection
  • Significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other diseases interfering with study or safety
  • Current use of opiates, alpha adrenergic agonists, metoclopramide, monoamine oxidase inhibitors, more than one serotonergic medication, or high doses of anticholinergic drugs (except if discontinued appropriately before study)
  • Treatment with GLP-1 agonists or amylin affecting vagal function
  • Bleeding or clotting disorders or use of medications increasing bleeding risk
  • Positive tissue transglutaminase antibody test
  • Pregnant or breastfeeding females
  • Known allergy or intolerance to eggs
  • Poor peripheral venous access without central access
  • Any other condition or prior therapy deemed unsuitable by the investigator
  • History of Long QT Syndrome or prolonged QT interval > 480 ms
  • Current symptoms of functional gastrointestinal disorder
  • Severe vomiting preventing tube placement or study participation
  • Structural cause of symptoms identified by endoscopy in past 12 months
  • Presence of gastric pacemakers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

K

Kelly J Feuerhak

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

6

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