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Recruiting NCT03865290

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

Phase II Interventional Indigestion Diabetes Mellitus

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ondansetron 8mg, Placebo.
Who it may be relevant to
Registry conditions: Indigestion, Diabetes Mellitus. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

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

Primary outcome measures

  • Change in severity of symptoms during enteral infusion [Time frame: baseline, every 15 minutes up to 8 hours]
  • Change in severity of symptoms during gastric emptying study [Time frame: baseline, every 15 minutes up to 2 hours]
  • Change in severity of daily symptoms [Time frame: Baseline, daily for six weeks]
  • Change in severity of gastrointestinal symptoms [Time frame: Baseline, 2 weeks, 6 weeks]
  • Change in severity of gastrointestinal symptoms effect on Quality of Life [Time frame: Baseline, 2 weeks, 6 weeks]
  • Change in effect of Gastrointestinal symptoms on Quality of Life [Time frame: Baseline]
Secondary outcome measures (10)
  • Glucose level [Time frame: baseline, approximately 60-120 minutes]
  • Insulin level [Time frame: baseline, approximately 60-120 minutes]
  • C-peptide level [Time frame: baseline, approximately 60-120 minutes]
  • Glucagon-like Peptide 1 (GLP-1) [Time frame: baseline, approximately 60-120 minutes]
  • Cholecystokinin (CCK) [Time frame: baseline, approximately 60-120 minutes]
  • Ghrelin [Time frame: baseline, approximately 60-120 minutes]
  • Peptide YY (PYY) [Time frame: baseline, approximately 60-120 minutes]
  • Plasma [Time frame: baseline, approximately 60-120 minutes]
  • Effect of gastrointestinal symptoms on Quality of Life - Nepean Dyspepsia index [Time frame: Baseline]
  • Severity of gastrointestinal symptoms - Nepean Dyspepsia index [Time frame: Baseline]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT03865290 · 18-005041 · P01DK068055

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗