Effects of risperidone on glucose metabolism and gut microbiota in healthy adults: an open-label, pilot, randomized controlled trial
- Conditions
- Healthy adults
- Registration Number
- JPRN-jRCTs041210165
- Lead Sponsor
- Oshima Megumi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 24
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method