UMIN-CTR Clinical Trial

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
Email	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
Email	naoki_washida@yahoo.co.jp

Sponsor
Institute	Keio University Division of Endocrinology, Metabolism and Nephrology Department of Internal Medicine
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015742