UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043014 |
|---|---|
| Receipt number | 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 14:25:49 |
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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
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
kasuyama-hs@umin.ac.jp
Sponsor or person
Institute
National Center for Global Health and Medicine Kohnodai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049106
