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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000018707
Receipt No. R000021647
Scientific Title Evaluation of the attribution of glycemic excursion after hemodialysis in patients with diabetes.
Date of disclosure of the study information 2015/08/18
Last modified on 2019/08/21

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Basic information
Public title Evaluation of the attribution of glycemic excursion after hemodialysis in patients with diabetes.
Acronym Evaluation of the glycemic profile in patients with diabetes on hemodialysis.
Scientific Title Evaluation of the attribution of glycemic excursion after hemodialysis in patients with diabetes.
Scientific Title:Acronym Evaluation of the glycemic profile in patients with diabetes on hemodialysis.
Region
Japan

Condition
Condition Patients with diabetes on hemodialysis
Classification by specialty
Medicine in general Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the attribution of glycemic excursion after hemodialysis in patients with diabetes by the difference of glycemic and hormonal profile between hemodialysis day and non-hemodialysis day.
Basic objectives2 Others
Basic objectives -Others To evaluate the attribution of glycemic excursion after hemodialysis in patients with diabetes
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Glycemic profile by using continuous glucose monitoring and contributing hormonal factors (Insulin, C-peptide, Glucagon, Growth hormone, ACTH, Cortisol)
Key secondary outcomes HbA1c and glycated albumin

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 For admitted patients, in the situation of taking same meals at same time between hemodialysis day and non-hemodialysis day, the glycemic profiles were collected by continuous glucose monitoring and the hormonal data were collected by blood samplings.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Stable dialysis prescription, 2)Currently hospitalization
Key exclusion criteria 1)Fever over 37.0 degreeC or overt infection disease, 2)Active malignant tumors, 3)Treatment with oral steroids, 4)Complicated with diseases influencing glycemic profile (e.g.Cushing syndrome, acromegaly, insulinoma, and dumping syndrome), 5)Pregnancy
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Akinori
Middle name
Last name Hayashi
Organization Kitasato University School of Medicine
Division name Endocrinology, Diabetes and Metabolism
Zip code 252-0374
Address 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL 042-778-8706
Email ahayashi@kitasato-u.ac.jp

Public contact
Name of contact person
1st name Akinori
Middle name
Last name Hayashi
Organization Kitasato University School of Medicine
Division name Endocrinology, Diabetes and Metabolism
Zip code 252-0374
Address 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL 042-778-8706
Homepage URL
Email ahayashi@kitasato-u.ac.jp

Sponsor
Institute Kitasato University School of Medicine. Division of Endocrinology, Diabetes and Metabolism.
Institute
Department

Funding Source
Organization Grant for Japanese Association of Dialysis Physicians and Self-funding
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization the Ethics Committee of Kitasato University Hospital
Address 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
Tel 042-778-7756
Email onoya@kitasato-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
2015 Year 08 Month 18 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 Main results already published
Date of protocol fixation
2014 Year 05 Month 01 Day
Date of IRB
2015 Year 07 Month 18 Day
Anticipated trial start date
2015 Year 07 Month 18 Day
Last follow-up date
2019 Year 08 Month 01 Day
Date of closure to data entry
2019 Year 08 Month 01 Day
Date trial data considered complete
2019 Year 08 Month 01 Day
Date analysis concluded
2019 Year 08 Month 01 Day

Other
Other related information From July 2015, the present study was performed. In the situation of taking same meals at same time between hemodialysis day and non-hemodialysis day, the glycemic profiles were collected by CGM and the hormonal data were collected by blood sampling.

Management information
Registered date
2015 Year 08 Month 18 Day
Last modified on
2019 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021647

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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