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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043014
Receipt No. R000049106
Scientific Title An observational study of the association between lipoprotein profile and the pathology in patients with type 2 diabetes
Date of disclosure of the study information 2021/01/15
Last modified on 2021/01/15

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Basic information
Public title The association between lipoprotein profile and the pathology in patients with type 2 diabetes
Acronym The association between lipoprotein profile and the pathology in patients with type 2 diabetes
Scientific Title An observational study of the association between lipoprotein profile and the pathology in patients with type 2 diabetes
Scientific Title:Acronym An observational study of the association between lipoprotein profile and the pathology in patients with type 2 diabetes
Region
Japan

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

Objectives
Narrative objectives1 To investigate the association between lipoprotein profile and the pathology in patients with type 2 diabetes
Basic objectives2 Others
Basic objectives -Others To investigate the change pf lipoprotein profile and the change of diabetic complications
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The correlations between lipoprotein profile and atherosclerosis/diabetic nephropathy
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 Patients with type 2 diabetes
Key exclusion criteria Patients who are hospitalized due to diseases except for diabetes
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Hisayuki
Middle name
Last name Katsuyama
Organization National Center for Global Health and Medicine Kohnodai Hospital
Division name Department of Diabetes, Endocrinology and Metabolism
Zip code 272-8516
Address 1-7-1 Kohnodai, Ichikawa-city, Chiba, Japan
TEL +81-47-372-3501
Email kasuyama-hs@umin.ac.jp

Public contact
Name of contact person
1st name Hisayuki
Middle name
Last name Katsuyama
Organization National Center for Global Health and Medicine Kohnodai Hospital
Division name Department of Diabetes, Endocrinology and Metabolism
Zip code 272-8516
Address 1-7-1 Kohnodai, Ichikawa-city, Chiba, Japan
TEL +81-47-372-3501
Homepage URL
Email kasuyama-hs@umin.ac.jp

Sponsor
Institute National Center for Global Health and Medicine Kohnodai Hospital
Institute
Department

Funding Source
Organization National Center for Global Health and Medicine Kohnodai 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 Certified Review Board of National Center for Global Health and Medicine
Address 1-21-1 Toyama Shinjuku-ku, Tokyo 162-8655, Japan
Tel +81-3-3202-7181
Email kenkyu-shinsa@hosp.ncgm.go.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
2021 Year 01 Month 15 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
2019 Year 11 Month 14 Day
Date of IRB
2020 Year 03 Month 06 Day
Anticipated trial start date
2021 Year 01 Month 12 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2021 Year 01 Month 15 Day
Last modified on
2021 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049106

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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