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| ID | Type | Description | Link |
|---|---|---|---|
| P01DK068055 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Control Ondansetron 8 mg | Experimental | Oral Ondansetron 8 mg administered in a single does dose during gastric emptying and duodenal infusion. |
|
| Diabetic (DM) gastroenteropathy Ondansetron 8 mg | Experimental | 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 |
|
| Non-ulcer dyspepsia (NUD) Ondansetron 8 mg | Experimental | 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 |
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| Healthy Control Placebo | Placebo Comparator | Oral matched placebo administered in a single does dose during gastric emptying and duodenal infusion. |
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| Diabetic (DM) gastroenteropathy Placebo | Placebo Comparator | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ondansetron 8mg | Drug | Oral Ondansetron 8 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose level | Compare the changes in glucose level during a lipid infusion | baseline, approximately 60-120 minutes |
| Insulin level | Compare the changes in insulin level during a lipid infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kelly J Feuerhak | Contact | 507-255-6802 | Feuerhak.Kelly@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Adil E Bharucha, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D004415 | Dyspepsia |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
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| ID | Term |
|---|---|
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Non-ulcer dyspepsia (NUD) Placebo | Placebo Comparator | 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 |
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| Placebo | Drug | Oral matched placebo |
|
| Baseline |
| baseline, approximately 60-120 minutes |
| C-peptide level | Compare the changes in C-peptide level during a lipid infusion | 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 | baseline, approximately 60-120 minutes |
| Cholecystokinin (CCK) | Compare the changes in Cholecystokinin (CCK) level during a lipid infusion | baseline, approximately 60-120 minutes |
| Ghrelin | Compare the changes in Ghrelin level during a lipid infusion | baseline, approximately 60-120 minutes |
| Peptide YY (PYY) | Compare the change in Peptide YY (PYY) level during a lipid infusion | baseline, approximately 60-120 minutes |
| Plasma | Compare the change in plasma level during a lipid infusion | 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 | 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 | Baseline |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D002227 |
| Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |