Effects of Body Clock Disruption on Gut Microbiota and Sleep Quality in Patients with Chronic Kidney Disease
Conditions
Interventions
None listed
Sponsors
Division of Kidney Health and Aging, the Center for Integrated Kidney Research and Advance,Shimane University Faculty of Medicine, Japan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Adult patients who are 18 years of age or older at the time of consent (ii) Cases in which the subject has given a full explanation of his/her participation in this study, and has given written consent of his/her own free will based on full understanding of the subject.
Exclusion criteria
Exclusion criteria: (1)Those with malignant disease or infection (2)Those who are at risk of aspiration (3)Patients with poor nutritional status(GNRI<90) (4)Those with hyponatremia (5)Those who do not have a smartphone (6)Those who cannot install the Fitbit application on their smartphones (7)Other cases that the principal investigator deems inappropriate as subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjects who agree to have their blood drawn multiple times a day will have their blood drawn twice a day at 12-hour intervals (e.g., 8:00 and 20:00) for one day on either schedule, and the expression levels of clock genes will be analyzed. 9.1 Primary endpoint The mean values of gut microbiota and each sleep parameter (total sleep time, sleep efficiency, sleep latency, mid-wake time, total time and percentage of deep sleep time, etc.) will be calculated to explore the relationship between gut microbiota and sleep in patients with CKD. 9.2 Secondary endpoints (1) Clock gene expression and amplitude will be measured (only for those who agree to multiple blood sampling). (2) Subjective sleep quality scored by subjective sleep assessment (OSA-MA), insomnia tendency and daytime sleepiness data (Athens Insomnia Scale, Epworth Sleepiness Scale Questionnaire) will be evaluated. (iii) Short-chain fatty acids, which are metabolites produced by the intestinal microflora, will be evaluated. (iv) To evaluate the questionnaire on defecation status. (5) To evaluate parameters of blood biochemistry. (6) Nutritional components obtained from dietary records will be evaluated. Based on the above, the effects of the intestinal environment, objective sleep evaluation, clock gene expression, subjective sleep evaluation, and defecation status will be explored and evaluated. | — |
Countries
Japan
Contacts
Public ContactUeda Seiji
Shimane University Faculty of Medicine Division of Kidney Health and Aging, the Center for Integrated Kidney Research and Advance
Outcome results
None listed