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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009891
Receipt No. R000011587
Scientific Title The study of characteristics of diurnal variation in blood glucose and the characteristics-associated markers in patients with chronic liver disease
Date of disclosure of the study information 2013/02/01
Last modified on 2013/01/28

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Basic information
Public title The study of characteristics of diurnal variation in blood glucose and the characteristics-associated markers in patients with chronic liver disease
Acronym variation in blood glucose and the characteristics-associated markers in patients with chronic liver disease
Scientific Title The study of characteristics of diurnal variation in blood glucose and the characteristics-associated markers in patients with chronic liver disease
Scientific Title:Acronym variation in blood glucose and the characteristics-associated markers in patients with chronic liver disease
Region
Japan

Condition
Condition chronic liver disease
Classification by specialty
Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The study of characteristics of diurnal variation in blood glucose and the characteristics-associated markers in patients with chronic liver disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The study of characteristics of diurnal variation in blood glucose by Continuous Glucose Monitoring System in patients with chronic liver disease
Key secondary outcomes

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 Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 1 Period; 48hour
2 Monitoring of blood glucose
by Glucose Monitoring System
3 Biochemical examination of blood and
somatometry
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
90 years-old >
Gender Male and Female
Key inclusion criteria 1 Patient of the chronic liver disease
Key exclusion criteria 1 Patient under medical treatment to
diabetes
2 Patient under medical treatment to
acute infection
3 Patient of bleeding tendency
4 Patient of hepatic encephalopathy
5 Patient under steroid treatment
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name HARIMA YUMIKO
Organization Yamaguchi university hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address Minamikogushi 1-1-1, Ube, Yamaguchi, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Yamaguchi university hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address
TEL 0836-22-2241
Homepage URL
Email

Sponsor
Institute Yamaguchi university hospital
Institute
Department

Funding Source
Organization Yamaguchi university 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
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

Other administrative information
Date of disclosure of the study information
2013 Year 02 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 Open public recruiting
Date of protocol fixation
2012 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 01 Month 28 Day
Last modified on
2013 Year 01 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011587

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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