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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034336
Receipt No. R000039146
Scientific Title Relationship between unaware hypoglycemia and cognitive function in dialysis patients
Date of disclosure of the study information 2018/10/01
Last modified on 2019/07/16

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Basic information
Public title Relationship between unaware hypoglycemia and cognitive function in dialysis patients
Acronym Relationship between unaware hypoglycemia and cognitive function in dialysis patients
Scientific Title Relationship between unaware hypoglycemia and cognitive function in dialysis patients
Scientific Title:Acronym Relationship between unaware hypoglycemia and cognitive function in dialysis patients
Region
Japan

Condition
Condition Chronic kidney disease
Classification by specialty
Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation on the frequency of unconscious hypoglycemia in chronic kidney disease and its involvement in cardiovascular disease development and cognitive decline.
Basic objectives2 Others
Basic objectives -Others Epidemiological Observation
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Frequency of unconscious hypoglycemia, and
the association with the onset of cardiovascular disease in the past year and current cognitive function.
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 Chronic kidney disease patients with reduced glomerular filtration volume of 60 ml / min or less and those under dialysis treatment, with and without diabetes.
Key exclusion criteria cachectic state of malignancy
progressed liver dysfunction
pregnancy
stage 3-4 cardiac failure
active infection
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Yasuyuki
Middle name
Last name Ushiogi
Organization Fukui-Saiseikai Hospital
Division name Nephrology
Zip code 918-8503
Address Wadanaka-cho Funabashi 7-1 Fukui Pref. Japan
TEL 0776-23-1111
Email ushiogi.yasuyuki3001@fukui.saiseikai.or.jp

Public contact
Name of contact person
1st name Yasuyuki
Middle name
Last name Ushiogi
Organization Fukui-Saiseikai Hospital
Division name Nephrology
Zip code 918-8503
Address Wadanaka-cho Funabashi 7-1 Fukui Pref. Japan
TEL 0776-23-1111
Homepage URL
Email ushiogi.yasuyuki3001@fukui.saiseikai.or.jp

Sponsor
Institute Fukui-Saiseikai Hospital
Institute
Department

Funding Source
Organization Fukui-Saiseikai Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Saiseikai-hosp. Ethics Review Board
Address Wadanaka-cho Funabashi 7-1 Fukui Pref. Japan
Tel 0776-23-1111
Email shp@fukui.saiseikai.or.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
2018 Year 10 Month 01 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 Enrolling by invitation
Date of protocol fixation
2018 Year 05 Month 01 Day
Date of IRB
2018 Year 05 Month 10 Day
Anticipated trial start date
2018 Year 06 Month 01 Day
Last follow-up date
2023 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Cross sectional study of single outpatient patients

Management information
Registered date
2018 Year 10 Month 01 Day
Last modified on
2019 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039146

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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