Healthy adults
Conditions
Interventions
Risperidone 0.5 mg, per oral, once per day, before bedtime, for 4 days
Sponsors
Oshima Megumi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HOMA-IR from baseline to day 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Changes in the variables from baseline to day 5; blood glucose, insulin, HbA1c, c-peptide, blood pressure, BMI, eGFR, Urinary albumin-creatinine ratio, amino acids, 16S rRNA 2) Adverse events | — |
Contacts
Public ContactMegumi Oshima
Kanazawa University Hospital
Outcome results
None listed