Pioglitazone for the Treatment of Idiopathic Gastroparesis (PIOGAS Study)
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Severity of Gastrointestinal Symptoms as Assessed by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index
研究概览
简要总结
The principal objective of this pilot study will be to evaluate whether 8 weeks of treatment of pioglitazone will improve symptoms as measured by the Gastrointestinal Symptom Index (GCSI) in patients with Idiopathic Gastroparesis.
详细描述
Objective • The principal objective of this pilot study will be to evaluate whether 8 weeks of treatment of pioglitazone will improve symptoms as measured by the Gastrointestinal Symptom Index Daily Diary (GCSI-DD) in patients with Idiopathic Gastroparesis
Secondary objectives of this study include:
- To determine the effects of pioglitazone on other symptoms associated with gastroparesis using the Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) and the Gastrointestinal Symptom Rating Scale (GSRS),
- To determine the effects of pioglitazone on gastric emptying as measured by the 13C- Spirulina breath test,
- To determine the effects of pioglitazone on satiety as measured by a liquid caloric test
- To determine the effects of pioglitazone on depression and anxiety using the Beck Depression Inventory and State-Trait Anxiety Scores,
- To determine the effects of pioglitazone on Quality of Life using the PAGI-QoL and Short Form (SF)-36 questionnaire,
- To determine the effects of pioglitazone on markers of inflammation (CRP and ESR) and serum cytokine levels
- To determine the nature and incidence of adverse effects from a 12-week course of pioglitazone.
Treatment group
• Pioglitazone (30 mg po qd)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older at registration
- •Diagnosis of gastroparesis as documented by gastric emptying scintigraphy (4-hour emptying after a low-fat meal with any combination of 2 and 4 hour retention of >60% and 10% respectively)
- •Ongoing symptoms referable to gastroparesis (i.e. Nausea and vomiting, bloating, and abdominal pain)
- •Exclusion of other causes of symptoms such as mechanical gastrointestinal obstruction, uncontrolled esophagitis, peptic ulcer disease, etc. By standard radiographic or endoscopic tests
- •Females will be required to use adequate contraceptive methods during study participation as determined by the Principal Investigator and the study team members
排除标准
- •Another active disorder, which could explain symptoms in the opinion of the investigator
- •Age < than 18 years
- •Pregnancy or nursing
- •Previous surgery of the upper gastrointestinal tract, including vagotomy
- •Another active disorder, which could explain symptoms in the opinion of the investigator
- •Use of narcotics more than 3 days per week
- •Significant hepatic injury as defined by significant alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevations of greater than 2 x upper limit of normal (ULN) or a Child-Pugh score of 10 or greater
- •Serious systemic disease, such as recent myocardial infarction/unstable angina, decompensated congestive heart failure, severe pulmonary disease with dyspnea at rest, or altered mental status from any cause
- •Diabetes as defined by HbA1c >6.5 and/or fasting blood sugar of >125 mg/DL
- •Contraindications to pioglitazone such as hypersensitivity or allergy
- •Concurrent use of: estradiol, ethynyl estradiol, mestranol, pazopanib, warfarin, digoxin, atorvastatin, ranitidine, gemfibrozil, fexofenadine, midazolam
- •Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study
- •History of bladder cancer or family history of bladder cancer
- •Failure to give informed consent
研究组 & 干预措施
Pioglitazone
Candidates who after the screening period are eligible to receive Pioglitazone
干预措施: Pioglitazone 30 mg (Drug)
结局指标
主要结局
Severity of Gastrointestinal Symptoms as Assessed by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index
时间窗: Baseline, later monthly up to 3 months.
The effect of Pioglitazone on nausea, early satiety, postprandial fullness, and upper abdominal pain as per changes in patient scoring in The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index (GCSI) which has been designed to assess symptoms associated with gastroparesis. Symptoms are rated as none (0), mild (1), moderate (2), severe (3), very severe (4) scale of the worst severity of the symptom over the last 24 hours. Values reported represent the mean participant scale choice.
次要结局
- Erythrocyte Sedimentation Rate (ESR)(Baseline and 2 months after treatment initiation)
- Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM)(Baseline and later monthly up to 3 months)
- Functional Status as Assessed by the SF-36v2 Health Survey(Baseline, later monthly up to 3 months)
- C- Reactive Protein Level in Blood(Baseline and 2 months after treatment initiation.)
- Mood as Assessed by the Beck Depression Inventory(Baseline, later monthly up to 3 months)
- Mood as Assessed by the State-Trait Anxiety Inventory(Baseline, later monthly up to 3 months)