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

Primary Purpose

Indigestion, Diabetes Mellitus

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Ondansetron 8mg

Placebo

About this trial

This is an interventional treatment trial for Indigestion

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Mayo Clinic in RochesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Arm Label

Healthy Control Ondansetron 8 mg

Diabetic (DM) gastroenteropathy Ondansetron 8 mg

Non-ulcer dyspepsia (NUD) Ondansetron 8 mg

Healthy Control Placebo

Diabetic (DM) gastroenteropathy Placebo

Non-ulcer dyspepsia (NUD) Placebo

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

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

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

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

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

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

Secondary Outcome Measures

Glucose level

Compare the changes in glucose level during a lipid infusion

Insulin level

Compare the changes in insulin level during a lipid infusion

C-peptide level

Compare the changes in C-peptide level during a lipid infusion

Glucagon-like Peptide 1 (GLP-1)

Compare the changes in Glucagon-like Peptide 1 (GLP-1) level during a lipid infusion

Cholecystokinin (CCK)

Compare the changes in Cholecystokinin (CCK) level during a lipid infusion

Ghrelin

Compare the changes in Ghrelin level during a lipid infusion

Peptide YY (PYY)

Compare the change in Peptide YY (PYY) level during a lipid infusion

Plasma

Compare the change in plasma level during a lipid infusion

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

Score is derived from 25 items pertaining to QOL

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

Full Information

NCT ID

NCT03865290

First Posted

February 14, 2019

Last Updated

May 26, 2023

Sponsor

Mayo Clinic

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03865290

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 2, 2019 (Actual)

Primary Completion Date

March 2025 (Anticipated)

Study Completion Date

March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Indigestion, Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Healthy Control Ondansetron 8 mg

Arm Type

Experimental

Arm Description

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

Arm Title

Diabetic (DM) gastroenteropathy Ondansetron 8 mg

Arm Type

Experimental

Arm Description

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

Arm Title

Non-ulcer dyspepsia (NUD) Ondansetron 8 mg

Arm Type

Experimental

Arm Description

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

Arm Title

Healthy Control Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Diabetic (DM) gastroenteropathy Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Non-ulcer dyspepsia (NUD) Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ondansetron 8mg

Other Intervention Name(s)

Zofran

Intervention Description

Oral Ondansetron 8 mg

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral matched placebo

Primary Outcome Measure Information:

Title

Change in severity of symptoms during enteral infusion

Description

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

Time Frame

baseline, every 15 minutes up to 8 hours

Title

Change in severity of symptoms during gastric emptying study

Description

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

Time Frame

baseline, every 15 minutes up to 2 hours

Title

Change in severity of daily symptoms

Description

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

Time Frame

Baseline, daily for six weeks

Title

Change in severity of gastrointestinal symptoms

Description

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

Time Frame

Baseline, 2 weeks, 6 weeks

Title

Change in severity of gastrointestinal symptoms effect on Quality of Life

Description

Time Frame

Baseline, 2 weeks, 6 weeks

Title

Change in effect of Gastrointestinal symptoms on Quality of Life

Description

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

Time Frame

Baseline

Secondary Outcome Measure Information:

Title

Glucose level

Description

Compare the changes in glucose level during a lipid infusion

Time Frame