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Effects of risperidone on glucose metabolism and gut microbiota in healthy adults: an open-label, pilot, randomized controlled trial

Effects of risperidone on glucose metabolism and gut microbiota in healthy adults: an open-label, pilot, randomized controlled trial

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The mean age was 35 and 29 years, one and two participants (30% and 50%) were male, and the mean eGFR was 90 and 92 ml/min/1.73 m2 in the risperidone and non-treated groups, respectively.

Of the eight participants who provided informed consent, one declined. Seven participants underwent randomization (three and four in the risperidone and non-treated groups, respectively) and completed the protocol treatment.

Among three participants in the risperidone group, somnolence occurred in two and abdominal discomfort occurred in one. No serious adverse events occurred.

Primary endpoint: There was no difference in the mean change from baseline in HOMA-IR at day 5 between the two groups. Secondary endpoint: The mean plasma and urine D-serine levels were increased in the risperidone group compared to the non-treated group. The fasting blood glucose was also increased in the risperidone group compared to the non-treated group. There were no differences in other secondary endpoints between the two groups.

Risperidone increased plasma and urine D-serine levels and did not affect HOMA-IR in healthy adults.

Mar. 07, 2024

No

None

https://jrct.mhlw.go.jp/latest-detail/jRCTs041210165

Oshima Megumi

Kanazawa University Hospital

13-1 Takara-machi, Kanazawa, Ishikawa, Japan

moshima@staff-kanazawa.u.ac.jp

Oshima Megumi

Kanazawa University Hospital

13-1 Takara-machi, Kanazawa, Ishikawa, Japan

+81-76-265-2499

moshima@staff-kanazawa.u.ac.jp

Complete

Mar. 22, 2022

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

single assignment

treatment purpose

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

Both

Healthy adults

Risperidone 0.5 mg, per oral, once per day, before bedtime, for 4 days

Change in HOMA-IR from baseline to day 5

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

+81-76-265-2048

Mar. 09, 2022

none