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

NCT ID: NCT03865290

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-02
• Study Completion Date: 2028-03-31

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.

Conditions

Indigestion; Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Healthy Control Ondansetron 8 mg

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

Group Type: EXPERIMENTAL

Ondansetron 8mg

Intervention Type: DRUG

Oral Ondansetron 8 mg

Diabetic (DM) gastroenteropathy Ondansetron 8 mg

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 Type: EXPERIMENTAL

Ondansetron 8mg

Intervention Type: DRUG

Oral Ondansetron 8 mg

Non-ulcer dyspepsia (NUD) Ondansetron 8 mg

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 Type: EXPERIMENTAL

Ondansetron 8mg

Intervention Type: DRUG

Oral Ondansetron 8 mg

Healthy Control Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral matched placebo

Diabetic (DM) gastroenteropathy Placebo

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 Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral matched placebo

Non-ulcer dyspepsia (NUD) Placebo

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 Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral matched placebo

Interventions

Ondansetron 8mg

Oral Ondansetron 8 mg

Intervention Type: DRUG

Placebo

Oral matched placebo

Intervention Type: DRUG

Other Intervention Names

Zofran

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Adil Bharucha, MBBS, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adil E Bharucha, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kelly J Feuerhak

Role: CONTACT

Feuerhak.Kelly@mayo.edu

507-255-6802

Facility Contacts

Kelly J Feuerhak

Role: primary

Feuerhak.Kelly@mayo.edu

507-255-6802

Other Identifiers

P01DK068055

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18-005041

Identifier Type: -

Identifier Source: org_study_id