Effects of Ondansetron on Gastrointestinal Sensorimotor Dysfunctions in Diabetes Mellitus and Dyspepsia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in severity of daily symptoms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Healthy Control Ondansetron 8 mg
Oral Ondansetron 8 mg administered in a single does dose during gastric emptying and duodenal infusion.
干预措施: Ondansetron 8mg (Drug)
Healthy Control Placebo
Oral matched placebo administered in a single does dose during gastric emptying and duodenal infusion.
干预措施: Placebo (Drug)
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
干预措施: Ondansetron 8mg (Drug)
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
干预措施: Ondansetron 8mg (Drug)
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
干预措施: Placebo (Drug)
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
干预措施: Placebo (Drug)
结局指标
主要结局
Change in severity of daily symptoms
时间窗: 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
Change in severity of gastrointestinal symptoms
时间窗: 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
Change in severity of gastrointestinal symptoms effect on Quality of Life
时间窗: 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
Change in severity of symptoms during enteral infusion
时间窗: 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
Change in effect of Gastrointestinal symptoms on Quality of Life
时间窗: 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
Change in severity of symptoms during gastric emptying study
时间窗: 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
次要结局
- Glucose level(baseline, approximately 60-120 minutes)
- C-peptide level(baseline, approximately 60-120 minutes)
- Glucagon-like Peptide 1 (GLP-1)(baseline, approximately 60-120 minutes)
- Peptide YY (PYY)(baseline, approximately 60-120 minutes)
- Effect of gastrointestinal symptoms on Quality of Life - Nepean Dyspepsia index(Baseline)
- Insulin level(baseline, approximately 60-120 minutes)
- Cholecystokinin (CCK)(baseline, approximately 60-120 minutes)
- Plasma(baseline, approximately 60-120 minutes)
- Severity of gastrointestinal symptoms - Nepean Dyspepsia index(Baseline)
- Ghrelin(baseline, approximately 60-120 minutes)
研究者
Adil Bharucha, MBBS, MD
Principal Investigator
Mayo Clinic