UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056200 |
|---|---|
| Receipt number | R000064218 |
| Scientific Title | Effects of Body Clock Disruption on Gut Microbiota and Sleep Quality in Patients with Chronic Kidney Disease |
| Date of disclosure of the study information | 2024/11/19 |
| Last modified on | 2024/11/19 18:25:18 |
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Basic information
Public title
Effects of Body Clock Disruption on Gut Microbiota and Sleep Quality in Patients with Chronic Kidney Disease
Acronym
Effects of Body Clock Disruption on Gut Microbiota and Sleep Quality in Patients with Chronic Kidney Disease
Scientific Title
Effects of Body Clock Disruption on Gut Microbiota and Sleep Quality in Patients with Chronic Kidney Disease
Scientific Title:Acronym
Effects of Body Clock Disruption on Gut Microbiota and Sleep Quality in Patients with Chronic Kidney Disease
Region
| Japan |
Condition
Condition
Effects of Body Clock Disruption on Gut Microbiota and Sleep Quality in Patients with Chronic Kidney Disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the prognostic impact of disrupted biological clocks in CKD patients and to determine if there is a relationship between the gut microbiota, sleep status, and expression of clock genes in CKD patients in clinical settings.
Basic objectives2
Others
Basic objectives -Others
No special note
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key 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.
Key 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
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ueda |
| Middle name | |
| Last name | Seiji |
Organization
Shimane University Faculty of Medicine
Division name
Division of Kidney Health and Aging, the Center for Integrated Kidney Research and Advance
Zip code
693-8501
Address
89-1 enyacho, Shimane, Japan
TEL
0853883135
se-ueda@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Ueda |
| Middle name | |
| Last name | Seiji |
Organization
Shimane University Faculty of Medicine
Division name
Division of Kidney Health and Aging, the Center for Integrated Kidney Research and Advance
Zip code
693-8501
Address
89-1 enyacho, Shimane, Japan
TEL
0853883135
Homepage URL
se-ueda@med.shimane-u.ac.jp
Sponsor or person
Institute
Division of Kidney Health and Aging, the Center for Integrated Kidney Research and Advance,Shimane University Faculty of Medicine, Japan
Institute
Department
Personal name
Funding Source
Organization
Division of Kidney Health and Aging, the Center for Integrated Kidney Research and Advance,Shimane University Faculty of Medicine, Japan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Division of Kidney Health and Aging, the Center for Integrated Kidney Research and Advance,Shimane University Faculty of Medicine, Japan
Address
89-1 enyacho, Shimane, Japan
Tel
0853883135
se-ueda@med.shimane-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All study subjects who participated in the observational study will be included in the analysis. However, if a study subject meets any of the following exclusion criteria for analysis, the investigator, sponsor, and collaborating institutions will discuss and decide how to handle the test values, etc. before opening the allocation list: 1) repeated violation of the indicated precautions, 3) it becomes clear after the study that the subject has violated the exclusion criteria, etc., 3) there are other obvious reasons for dropping out (3) When there are other clear reasons for the dropout.
For missing values and outliers, the handling of test values, etc. shall be determined prior to opening the allocation table after considering the cause.
Management information
Registered date
| 2024 | Year | 11 | Month | 19 | Day |
Last modified on
| 2024 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064218
