JPRN-jRCTs041210165暂停1 期
Effects of risperidone on glucose metabolism and gut microbiota in healthy adults: an open-label, pilot, randomized controlled trial
Oshima Megumi0 个研究点目标入组 24 人开始时间: 2022年3月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 65age old(—)
- 性别
- All
入选标准
- •The study includes those who meet all of the following criteria.
- •1) Men and women between the ages of 20 and 65
- •2) No history of psychiatric or neurological disorders
- •3) Fasting blood glucose level less than 140 mg/dL
- •4) HOMA-IR (homeostasis model assessment-insulin resistance) 1.6 or higher
- •5) Estimated GFR 60 ml/min/1.73 m2 or higher
- •6) AST and ALT less than 30 IU/L
- •7) No history of arrhythmia or congenital QT prolongation syndrome
- •8) No history of active cancer (disease-free for 5 years or less)
- •9) Have a bowel movement at least once every 4 days (regardless of whether or not laxatives are used)
- •10) The patient's written consent has been obtained after sufficient informed consent for participation in the study
排除标准
- •Illnesses under treatment
- •History of hypersensitivity to any of the ingredients of risperidone or paliperidone
- •Pregnant or lactating mothers
- •Participation in other clinical studies within 3 months prior to the start of administration of the study drug
- •Not appropriate as participants
- •Working at the same or related departments as the principal investigator
研究者
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