UMIN-CTR Clinical Trial

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