UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013483 |
|---|---|
| Receipt number | R000015742 |
| Scientific Title | The effect of the uremia and dialysis on circadian rhythm in blood glucose and blood pressure in the end-stage renal disease |
| Date of disclosure of the study information | 2014/03/22 |
| Last modified on | 2019/09/25 09:25:25 |
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Basic information
Public title
The effect of the uremia and dialysis on circadian rhythm in blood glucose and blood pressure in the end-stage renal disease
Acronym
The circadian rhythm in blood glucose in the end-stage renal failure and dialysis patients
Scientific Title
The effect of the uremia and dialysis on circadian rhythm in blood glucose and blood pressure in the end-stage renal disease
Scientific Title:Acronym
The circadian rhythm in blood glucose in the end-stage renal failure and dialysis patients
Region
| Japan |
Condition
Condition
end-stage renal failure
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of the uremia and dialysis on circadian rhythm in blood glucose using CGM (continuous glucose monitoring) in the end-stage renal failure and dialysis patients, and to take measures against the big fluctuation of blood glucose and hypoglycemia
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
circadian rhythm in blood glucose using CGM
Key secondary outcomes
The change in
1) fasting glood glusoce
2) blood glucose before, during and after dialysis
3) blood pressure
4) dialysis dose
5) serum creatinine
6) plasma glucagon concetration
7) plasma beta2MG concentration
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)hospitalized patients for the induction of hemodialysis or peritoneal dialysis
2)no anamnestic renal transplantation
3)outpatients above the chronic renal disease stage 4
Key exclusion criteria
1)the subjects found offensive by attending physicians for this research (onsetting of dementia, phycological diseases and so on)
2)the subjects who have renal transplantation
3)the subjects with the chronic inflammation
4)the subjects who need internal medicines, such as steroid drugs, influencing endocrinological systems
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Washida |
Organization
Keio University School of Medicine
Division name
Integrated renal replacement therapy translational medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3878
naoki_washida@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Washida |
Organization
Keio University School of Medicine
Division name
Integrated renal replacement therapy translational medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3878
Homepage URL
naoki_washida@yahoo.co.jp
Sponsor or person
Institute
Keio University Division of Endocrinology, Metabolism and Nephrology Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine
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
Address
Tel
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
慶應義塾大学病院（東京都）、埼玉社会保険病院（埼玉県）、済生会中央病院（東京都）、川崎市立井田病院（神奈川県）
Keio University Hospital(Tokyo), Saitama Social Insurance Hospital(Saitama), Saiseikai Central Hospital(Tokyo), Kawasaki Municipal Ida Hospital(Kanagawa)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 22 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2014 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2014 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The comparison between the circadian rhythm of blood glucose before and after the induction of hemodialysis/peritoneal dialysis, using the CGMs. Furthermore, the glucose swing will be evaluated on 6 and 12 months after the induction of dialysis, using the CGMs.
Management information
Registered date
| 2014 | Year | 03 | Month | 22 | Day |
Last modified on
| 2019 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015742
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
