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临床试验/JPRN-jRCTs041210165
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

发起方
Oshima Megumi

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