UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020666 |
|---|---|
| Receipt number | R000023784 |
| Scientific Title | Advanced Best Care in Diabetes Study |
| Date of disclosure of the study information | 2016/01/20 |
| Last modified on | 2021/01/26 15:31:45 |
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Basic information
Public title
Advanced Best Care in Diabetes Study
Acronym
ABCD Study
Scientific Title
Advanced Best Care in Diabetes Study
Scientific Title:Acronym
ABCD Study
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is aimed to clarify key factors relating to the development of diabetes and its complications.
Basic objectives2
Others
Basic objectives -Others
This study is an observational study to search laboratory data, medical treatments, development of diabetic complications.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1 diabetic nephrology
2 diabetic retinopathy
3 diabetic neuropathy
4 ischemic heart diseases, heart failure
5 stroke
6 peripheral arterial diseases
7 osteoporosis
Key secondary outcomes
1 blood glucose, HbA1c, glycol-albumin, 1,5-AG, fasting-IRI
2 lipids, blood pressures, body weight
3 CRP, BNP
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
diabetic patients
Key exclusion criteria
patients who decline to be enrolled in this study
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norikazu Maeda |
Organization
Graduate School of Medicine, Osaka University
Division name
Metabolic Medicine/Metabolism and Atherosclerosis
Zip code
Address
2-2-B5, Yamada-oka, Suita, Osaka, Japan
TEL
06-6879-3737
norikazu_maeda@endmet.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norikazu Maeda |
Organization
Graduate School of Medicine, Osaka University
Division name
Metabolic Medicine/Metabolism and Atherosclerosis
Zip code
Address
2-2-B5, Yamada-oka, Suita, Osaka, Japan
TEL
06-6879-3737
Homepage URL
norikazu_maeda@endmet.med.osaka-u.ac.jp
Sponsor or person
Institute
Departments of Metabolic Medicine/Metabolism and Atherosclerosis, Graduate School of Medicine, Osaka University
Institute
Department
Personal name
Funding Source
Organization
Departments of Metabolic Medicine/Metabolism and Atherosclerosis, Graduate School of Medicine, Osaka University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 01 | Month | 20 | 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
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 13 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 13 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 13 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
This study is an observational retrospective study. Diabetic participants are enrolled from 8/Feb/2016 to 31/Mar/2020. Ordinary laboratory examinations, medications, diabetic complications, and diseases relating to diabetes are analyzed.
Management information
Registered date
| 2016 | Year | 01 | Month | 20 | Day |
Last modified on
| 2021 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023784
