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

ConditionsIndigestionDiabetes Mellitus
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ondansetron 8mg

    Drug

    Oral Ondansetron 8 mg

  • Placebo

    Drug

    Oral matched placebo

Treatment groups

150 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Healthy Control Ondansetron 8 mgExperimental treatment 1 intervention
Group B: Diabetic (DM) gastroenteropathy Ondansetron 8 mgExperimental treatment 1 intervention
Group C: Non-ulcer dyspepsia (NUD) Ondansetron 8 mgExperimental treatment 1 intervention
Group D: Healthy Control PlaceboPlacebo comparator 1 intervention
Group E: Diabetic (DM) gastroenteropathy PlaceboPlacebo comparator 1 intervention
Group F: Non-ulcer dyspepsia (NUD) PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
baseline, every 15 minutes up to 8 hours
2

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

Time frame
baseline, every 15 minutes up to 2 hours
3

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

Time frame
Baseline, daily for six weeks
4

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

Time frame
Baseline, 2 weeks, 6 weeks

Secondary outcomes

1

Glucose level

Compare the changes in glucose level during a lipid infusion

Time frame
baseline, approximately 60-120 minutes
2

Insulin level

Compare the changes in insulin level during a lipid infusion

Time frame
baseline, approximately 60-120 minutes
3

C-peptide level

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

Time frame
baseline, approximately 60-120 minutes
4

Glucagon-like Peptide 1 (GLP-1)

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

Time frame
baseline, approximately 60-120 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov
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