UMIN ID: UMIN000056200
Registered date:19/11/2024
Effects of Body Clock Disruption on Gut Microbiota and Sleep Quality in Patients with Chronic Kidney Disease
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Effects of Body Clock Disruption on Gut Microbiota and Sleep Quality in Patients with Chronic Kidney Disease |
| Date of first enrollment | 2024/10/01 |
| Target sample size | 50 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | 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. |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 18years-old |
|---|---|
| Age maximum | 100years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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 |
Related Information
| Primary Sponsor | Division of Kidney Health and Aging, the Center for Integrated Kidney Research and Advance,Shimane University Faculty of Medicine, Japan |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Division of Kidney Health and Aging, the Center for Integrated Kidney Research and Advance,Shimane University Faculty of Medicine, Japan |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Ueda Seiji |
| Address | 89-1 enyacho, Shimane, Japan Japan 693-8501 |
| Telephone | 0853883135 |
| se-ueda@med.shimane-u.ac.jp | |
| Affiliation | Shimane University Faculty of Medicine Division of Kidney Health and Aging, the Center for Integrated Kidney Research and Advance |
| scientific contact | |
| Name | Ueda Seiji |
| Address | 89-1 enyacho, Shimane, Japan Japan |
| Telephone | 0853883135 |
| se-ueda@med.shimane-u.ac.jp | |
| Affiliation | Shimane University Faculty of Medicine Division of Kidney Health and Aging, the Center for Integrated Kidney Research and Advance |