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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03865290
• Other study ID #: 18-005041
• Secondary ID: P01DK068055
• Status: Recruiting
• Phase: Phase 2
• Start date: April 2, 2019
• Est. completion date: March 2026

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: Kelly J Feuerhak
• Phone: 507-255-6802
• Email: Feuerhak.Kelly[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The primary objectives of this study are to evaluate the effects of ondansetron, on symptoms (i) during a gastric emptying study, (ii) during enteral lipid infusion and (iii) in daily life.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 2026
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Dyspepsia
• Indigestion

Intervention

Drug:
• Ondansetron 8mg
Oral Ondansetron 8 mg
• Placebo
Oral matched placebo

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in severity of symptoms during enteral infusion	Visual analog scale (VAS) used to measure the change in symptom severity with a scale of 0=absent, 1=light, 2=moderate, 3=severe, 4=intolerable	baseline, every 15 minutes up to 8 hours
Primary	Change in severity of symptoms during gastric emptying study	Visual analog scale (VAS) used to measure the change in symptom severity with a scale of 0=absent, 1=light, 2=moderate, 3=severe, 4=intolerable	baseline, every 15 minutes up to 2 hours
Primary	Change in severity of daily symptoms	Gastroparesis Cardinal Symptom Index - Daily Diary (GCSI-DD) used to measure the change in symptoms severity with a scale of 0=none, 1= very mild, 2=mild,3=moderate, 4=severe, 5= very severe	Baseline, daily for six weeks
Primary	Change in severity of gastrointestinal symptoms	Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) used to measure the change in symptoms severity with a scale of 0=none, 1= very mild, 2=mild,3=moderate, 4=severe, 5= very severe	Baseline, 2 weeks, 6 weeks
Primary	Change in severity of gastrointestinal symptoms effect on Quality of Life	Gastrointestinal Disorders - Quality of Life and Well-Being (PAGI-QOL) used to measure the change in symptoms severity with a scale of 0=none, 1= very mild, 2=mild,3=moderate, 4=severe, 5= very severe	Baseline, 2 weeks, 6 weeks
Primary	Change in effect of Gastrointestinal symptoms on Quality of Life	Nepean Dyspepsia Index used to measure symptoms severity with a scale of 0=none, 1= very mild, 2=mild,3=moderate, 4=severe, 5= very severe	Baseline
Secondary	Glucose level	Compare the changes in glucose level during a lipid infusion	baseline, approximately 60-120 minutes
Secondary	Insulin level	Compare the changes in insulin level during a lipid infusion	baseline, approximately 60-120 minutes
Secondary	C-peptide level	Compare the changes in C-peptide level during a lipid infusion	baseline, approximately 60-120 minutes
Secondary	Glucagon-like Peptide 1 (GLP-1)	Compare the changes in Glucagon-like Peptide 1 (GLP-1) level during a lipid infusion	baseline, approximately 60-120 minutes
Secondary	Cholecystokinin (CCK)	Compare the changes in Cholecystokinin (CCK) level during a lipid infusion	baseline, approximately 60-120 minutes
Secondary	Ghrelin	Compare the changes in Ghrelin level during a lipid infusion	baseline, approximately 60-120 minutes
Secondary	Peptide YY (PYY)	Compare the change in Peptide YY (PYY) level during a lipid infusion	baseline, approximately 60-120 minutes
Secondary	Plasma	Compare the change in plasma level during a lipid infusion	baseline, approximately 60-120 minutes
Secondary	Effect of gastrointestinal symptoms on Quality of Life - Nepean Dyspepsia index	Score is derived from 25 items pertaining to QOL	Baseline
Secondary	Severity of gastrointestinal symptoms - Nepean Dyspepsia index	Nepean Dyspepsia Index is used to measure symptom severity with a scale of 0=none, 1= very mild, 2=mild,3=moderate, 4=severe, 5= very severe	Baseline