Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 16 of 41 for:    Recruiting, Not yet recruiting, Available Studies | Dyspepsia

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03865290
Recruitment Status : Recruiting
First Posted : March 6, 2019
Last Update Posted : May 14, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Adil Bharucha, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Indigestion Diabetes Mellitus Drug: Ondansetron 8mg Drug: Placebo Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Ondansetron on Gastrointestinal Sensorimotor Dysfunctions in Diabetes Mellitus and Dyspepsia
Actual Study Start Date : April 2, 2019
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : March 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arm Intervention/treatment
Experimental: Healthy Control Ondansetron 8 mg
Oral Ondansetron 8 mg administered in a single does dose during gastric emptying and duodenal infusion.
Drug: Ondansetron 8mg
Oral Ondansetron 8 mg
Other Name: Zofran

Experimental: 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

Drug: Ondansetron 8mg
Oral Ondansetron 8 mg
Other Name: Zofran

Experimental: 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

Drug: Ondansetron 8mg
Oral Ondansetron 8 mg
Other Name: Zofran

Placebo Comparator: Healthy Control Placebo
Oral matched placebo administered in a single does dose during gastric emptying and duodenal infusion.
Drug: Placebo
Oral matched placebo

Placebo Comparator: 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

Drug: Placebo
Oral matched placebo

Placebo Comparator: 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

Drug: Placebo
Oral matched placebo




Primary Outcome Measures :
  1. Change in severity of symptoms during enteral infusion [ Time Frame: baseline, every 15 minutes up to 8 hours ]
    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

  2. Change in severity of symptoms during gastric emptying study [ Time Frame: baseline, every 15 minutes up to 2 hours ]
    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

  3. Change in severity of daily symptoms [ Time Frame: Baseline, daily for six weeks ]
    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

  4. Change in severity of gastrointestinal symptoms [ Time Frame: Baseline, 2 weeks, 6 weeks ]
    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

  5. Change in severity of gastrointestinal symptoms effect on Quality of Life [ Time Frame: Baseline, 2 weeks, 6 weeks ]
    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

  6. Change in effect of Gastrointestinal symptoms on Quality of Life [ Time Frame: Baseline ]
    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 :
  1. Glucose level [ Time Frame: baseline, approximately 60-120 minutes ]
    Compare the changes in glucose level during a lipid infusion

  2. Insulin level [ Time Frame: baseline, approximately 60-120 minutes ]
    Compare the changes in insulin level during a lipid infusion

  3. C-peptide level [ Time Frame: baseline, approximately 60-120 minutes ]
    Compare the changes in C-peptide level during a lipid infusion

  4. Glucagon-like Peptide 1 (GLP-1) [ Time Frame: baseline, approximately 60-120 minutes ]
    Compare the changes in Glucagon-like Peptide 1 (GLP-1) level during a lipid infusion

  5. Cholecystokinin (CCK) [ Time Frame: baseline, approximately 60-120 minutes ]
    Compare the changes in Cholecystokinin (CCK) level during a lipid infusion

  6. Ghrelin [ Time Frame: baseline, approximately 60-120 minutes ]
    Compare the changes in Ghrelin level during a lipid infusion

  7. Peptide YY (PYY) [ Time Frame: baseline, approximately 60-120 minutes ]
    Compare the change in Peptide YY (PYY) level during a lipid infusion

  8. Plasma [ Time Frame: baseline, approximately 60-120 minutes ]
    Compare the change in plasma level during a lipid infusion

  9. Effect of gastrointestinal symptoms on Quality of Life - Nepean Dyspepsia index [ Time Frame: Baseline ]
    Score is derived from 25 items pertaining to QOL

  10. Severity of gastrointestinal symptoms - Nepean Dyspepsia index [ Time Frame: Baseline ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03865290


Contacts
Layout table for location contacts
Contact: Kelly J Feuerhak 507-255-6802 Feuerhak.Kelly@mayo.edu

Locations
Layout table for location information
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Kelly J Feuerhak    507-255-6802    Feuerhak.Kelly@mayo.edu   
Principal Investigator: Adil E Bharucha, MD         
Sponsors and Collaborators
Mayo Clinic
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Layout table for investigator information
Principal Investigator: Adil E Bharucha, MD Mayo Clinic

Additional Information:
Layout table for additonal information
Responsible Party: Adil Bharucha, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03865290     History of Changes
Other Study ID Numbers: 18-005041
P01DK068055 ( U.S. NIH Grant/Contract )
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Dyspepsia
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents