UMIN-CTR Clinical Trial

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 Akinobu Middle name Last name Nakamura
Organization	Hokkaido University Hospital
Division name	Internal medicine II
Zip code	060-8638
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 Akinobu Middle name Last name Nakamura
Organization	Hokkaido University Hospital
Division name	Internal medicine II
Zip code	060-8638
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	Hokkaido University Hospital Clinical Research and Medical Innovation Center
Address	N-14, W-5, Kita-ku, Sapporo, Hokkaido, Japan
Tel	011-706-7061
Email	crjimu@huhp.hokudai.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	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	311
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	Completed
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	2020 Year 04 Month 26 Day

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