Investigating Ondansetron's Effects on Digestive Issues in Diabetes and Indigestion

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to explore the gastrointestinal symptoms experienced by individuals with diabetes mellitus and indigestion, focusing on their sensitivity to nutrients in the small intestine. Researchers will evaluate the effects of ondansetron, a medication commonly used to treat nausea, on gastrointestinal function and associated symptoms through various assessments, including gastric emptying studies and daily life evaluations. Participants will receive either ondansetron or a placebo to determine the medication's efficacy in alleviating symptoms.

Why it matters

Who can join: the full rules

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

Where it's running

• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Adil E Bharucha, MD — Mayo Clinic
• Study coordinator: Kelly J Feuerhak
• Email: Feuerhak.Kelly@mayo.edu
• Phone: 507-255-6802

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.