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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
Oral Ondansetron 8 mg
Oral matched placebo
Mayo Clinic in Rochester
Rochester, Minnesota, United States
RECRUITINGChange 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
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
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
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
Change in severity of gastrointestinal symptoms effect on Quality of Life
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
Time frame: Baseline, 2 weeks, 6 weeks
Change in effect of Gastrointestinal symptoms on Quality of Life
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
Time frame: Baseline
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Glucose level
Compare the changes in glucose level during a lipid infusion
Time frame: baseline, approximately 60-120 minutes
Insulin level
Compare the changes in insulin level during a lipid infusion
Time frame: baseline, approximately 60-120 minutes
C-peptide level
Compare the changes in C-peptide level during a lipid infusion
Time frame: baseline, approximately 60-120 minutes
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
Cholecystokinin (CCK)
Compare the changes in Cholecystokinin (CCK) level during a lipid infusion
Time frame: baseline, approximately 60-120 minutes
Ghrelin
Compare the changes in Ghrelin level during a lipid infusion
Time frame: baseline, approximately 60-120 minutes
Peptide YY (PYY)
Compare the change in Peptide YY (PYY) level during a lipid infusion
Time frame: baseline, approximately 60-120 minutes
Plasma
Compare the change in plasma level during a lipid infusion
Time frame: baseline, approximately 60-120 minutes
Effect of gastrointestinal symptoms on Quality of Life - Nepean Dyspepsia index
Score is derived from 25 items pertaining to QOL
Time frame: Baseline
Severity of gastrointestinal symptoms - Nepean Dyspepsia index
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
Time frame: Baseline