RECRUITING

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-04-02

Study Completion:2026-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03865290

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Healthy male or non-pregnant, non-breastfeeding female volunteers; * 18-75 years old; * Able to provide written informed consent before participating in the study * Able to communicate adequately with the investigator and to comply with the requirements for the entire study; including the willingness and ability to consume the components of the test meals * Symptoms of dyspepsia (i.e., early satiety, postprandial discomfort, nausea, vomiting, regurgitation) * 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	* Major abdominal surgery (i.e., appendectomy, cholecystectomy, tubal ligation, hysterectomy, herniorrhaphy, and limited colonic resection are permissible) * Clinical evidence (including physical exam and EKG) of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns * Current use of opiates, alpha adrenergic agonists, metoclopramide, monoamine oxidase inhibitors, more than one serotonergic medication, and high doses of anticholinergic agents (eg, amitriptyline greater than 50 mg daily). If medically safe, these drugs may be discontinued for four half lives prior to study assessments. * Treatment with GLP-1 agonists and amlyin which cause vagal blockade and may affect central processing of pain * Bleeding or clotting disorders or medications that increase risk of bleeding from mucosal biopsies * Positive tissue transglutaminase antibodies (TTG), * Pregnant or breast-feeding females * Known intolerance or allergy to eggs * Poor peripheral venous access, if central venous access is not available * Any other condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study * History of Long QT Syndrome or prolonged QT interval (i.e., corrected QT interval \> 480 ms) * Current symptoms of a functional gastrointestinal disorder assessed by questionnaire * Severe vomiting that would preclude tube placement or participation in the study * Structural cause for symptoms by endoscopy within the past 12 months * Patients with gastric pacemakers

Inclusion Criteria

Exclusion Criteria

* Healthy male or non-pregnant, non-breastfeeding female volunteers;
* 18-75 years old;
* Able to provide written informed consent before participating in the study
* Able to communicate adequately with the investigator and to comply with the requirements for the entire study; including the willingness and ability to consume the components of the test meals
* Symptoms of dyspepsia (i.e., early satiety, postprandial discomfort, nausea, vomiting, regurgitation)
* 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

* Major abdominal surgery (i.e., appendectomy, cholecystectomy, tubal ligation, hysterectomy, herniorrhaphy, and limited colonic resection are permissible)
* Clinical evidence (including physical exam and EKG) of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns
* Current use of opiates, alpha adrenergic agonists, metoclopramide, monoamine oxidase inhibitors, more than one serotonergic medication, and high doses of anticholinergic agents (eg, amitriptyline greater than 50 mg daily). If medically safe, these drugs may be discontinued for four half lives prior to study assessments.
* Treatment with GLP-1 agonists and amlyin which cause vagal blockade and may affect central processing of pain
* Bleeding or clotting disorders or medications that increase risk of bleeding from mucosal biopsies
* Positive tissue transglutaminase antibodies (TTG),
* Pregnant or breast-feeding females
* Known intolerance or allergy to eggs
* Poor peripheral venous access, if central venous access is not available
* Any other condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study
* History of Long QT Syndrome or prolonged QT interval (i.e., corrected QT interval \> 480 ms)
* Current symptoms of a functional gastrointestinal disorder assessed by questionnaire
* Severe vomiting that would preclude tube placement or participation in the study
* Structural cause for symptoms by endoscopy within the past 12 months
* Patients with gastric pacemakers

Contacts and Locations

Study Contact

Kelly J Feuerhak

CONTACT

507-255-6802

Feuerhak.Kelly@mayo.edu

Principal Investigator

Adil E Bharucha, MD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Adil E Bharucha, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-04-02

Study Completion Date2026-03

Study Record Updates

Study Start Date2019-04-02

Study Completion Date2026-03

Terms related to this study

Additional Relevant MeSH Terms

Indigestion
Diabetes Mellitus