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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029993
Receipt No. R000034252
Scientific Title The association between hypoglycemia or glucose fluctuation and diabetes-related complications or disorders in Japanese patients with type 2 diabetes
Date of disclosure of the study information 2017/11/16
Last modified on 2019/04/08

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Basic information
Public title The association between hypoglycemia or glucose fluctuation and diabetes-related complications or disorders in Japanese patients with type 2 diabetes
Acronym The association between hypoglycemia or glucose fluctuation and diabetes-related complications or disorders
Scientific Title The association between hypoglycemia or glucose fluctuation and diabetes-related complications or disorders in Japanese patients with type 2 diabetes
Scientific Title:Acronym The association between hypoglycemia or glucose fluctuation and diabetes-related complications or disorders
Region
Japan

Condition
Condition type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of our study is to examine whether hypoglycemia or glucose fluctuation are associated with the onset and worsening of diabetes-related complications or disorders in Japanese patients with type 2 diabetes.
Basic objectives2 Others
Basic objectives -Others To extract factors to increase hypoglycemia or glucose fluctuation in Japanese patients with type 2 diabetes.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The association between glucose fluctuation and clinical characteristics, glucose-related parameters or insulin secretion.
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 1) 20 years of age or more
2) Patients undergoing glucose monitoring
3) Written informed consent
Key exclusion criteria 1) Patients hospitalized within the past three months
2) Severe diabetic ketosis, diabetic coma within the past six months
3) Pregnancy, nursing woman or possibly pregnant woman
4) Patients who are taking kinds of steroid
5) Type 1 diabetes
6) Severe infection, pre and post operation, severe trauma
7) Patients haing difficulty in dietary intake
8) Patients who thought to be inappropriate to enter this study for some reasons by physician's judgments
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akinobu Nakamura
Organization Hokkaido University Hospital
Division name Internal medicine II
Zip code
Address N-14, W-5, Kita-ku, Sapporo, Hokkaido, Japan
TEL 011-706-5915
Email akinbo@tim.hi-ho.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akinobu Nakamura
Organization Hokkaido University Hospital
Division name Internal medicine II
Zip code
Address N-14, W-5, Kita-ku, Sapporo, Hokkaido, Japan
TEL 011-706-5915
Homepage URL
Email akinbo@tim.hi-ho.ne.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization Hokkaido University Hospital
Organization
Division
Category of Funding Organization Other
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
2017 Year 11 Month 16 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
2017 Year 10 Month 18 Day
Date of IRB
2017 Year 10 Month 18 Day
Anticipated trial start date
2018 Year 01 Month 01 Day
Last follow-up date
2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is an observational study.

Management information
Registered date
2017 Year 11 Month 15 Day
Last modified on
2019 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034252

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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