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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029698
Receipt No. R000033943
Scientific Title Hemodialysis-induced hypoglycemia and disarrays in patients with glycemic diabetes: a retrospective study.
Date of disclosure of the study information 2017/10/25
Last modified on 2019/04/27

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Basic information
Public title Hemodialysis-induced hypoglycemia and disarrays in patients with glycemic diabetes: a retrospective study.
Acronym HD-induced hypoglycemia and glycemic disarrays in diabetic patients.
Scientific Title Hemodialysis-induced hypoglycemia and disarrays in patients with glycemic diabetes: a retrospective study.
Scientific Title:Acronym HD-induced hypoglycemia and glycemic disarrays in diabetic patients.
Region
Japan

Condition
Condition Diabetic hemodialysis patients
Classification by specialty
Medicine in general Endocrinology and Metabolism Nephrology
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We retrospectively analyze the glycemic profiles on both hemodialysis day / non-hemodialysis day in diabetic hemodialysis patients by continuous glucose monitoring (CGM) and reveal of the hemodialysis-induced hypoglycemia and glycemic disarrays often, factors that contribute to them.
Basic objectives2 Others
Basic objectives -Others Glycemic profiles by CGM, HbA1c and glycated albumin.
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The frequency of hemodialysis-induced hypoglycemia and glycemic disarray and its factors.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Diabetic hemodialysis patients who previously attached CGM in Kitasato University Hospital and Soubudai Nieren Clinic
Key exclusion criteria (1) Patients with insufficient CGM data
(2) Patients with insufficient blood test results
(3) Patients who refused to participant this study
Target sample size 138

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, Department of Endocrinology, Diabetes and Metabolism
Institute
Department

Funding Source
Organization Self-funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Soubudai Nieren clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kitasato University Medical Ethics Organization
Address 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
Tel 042-778-8273
Email rinrib@med.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 北里大学病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 25 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 138
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason During data analysis
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 No longer recruiting
Date of protocol fixation
2017 Year 10 Month 24 Day
Date of IRB
2017 Year 10 Month 23 Day
Anticipated trial start date
2017 Year 10 Month 24 Day
Last follow-up date
2018 Year 04 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Diabetic hemodialysis patients
Continuous glucose monitoring
Hemodialysis-related hypoglycemia
Hemodialysis-induced glycemic disarrays

Management information
Registered date
2017 Year 10 Month 25 Day
Last modified on
2019 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033943

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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