UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048469 |
|---|---|
| Receipt number | R000055239 |
| Scientific Title | Diabetic Registry in Chikugo District |
| Date of disclosure of the study information | 2022/07/26 |
| Last modified on | 2022/07/26 17:34:48 |
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Basic information
Public title
Diabetic Registry in Chikugo District
Acronym
Diabetic Registry in Chikugo District
Scientific Title
Diabetic Registry in Chikugo District
Scientific Title:Acronym
Diabetic Registry in Chikugo District
Region
| Japan |
Condition
Condition
Diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to establish a database for improving the treatment of diabetes.
Basic objectives2
Others
Basic objectives -Others
Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Distribution of various parameters related to glucose metabolism
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients, except those who did not wish to be enrolled in the study, were informed of the study by posting the details of the study on the website.
Key exclusion criteria
Patients who did not wish to be enrolled in this study
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiko |
| Middle name | |
| Last name | Wada |
Organization
Department of Internal Medicine, Kurume University School of Medicine
Division name
Division of Endocrinology and Metabolism
Zip code
830-0011
Address
67 Asahi-machi, Kurume-shi, Fukuoka, Japan
TEL
0942-31-7563
wada_nobuhiko@kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Nobuhiko |
| Middle name | |
| Last name | Wada |
Organization
Department of Internal Medicine, Kurume University School of Medicine
Division name
Division of Endocrinology and Metabolism
Zip code
830-0011
Address
67 Asahi-machi, Kurume-shi, Fukuoka, Japan
TEL
0942-31-7563
Homepage URL
wada_nobuhiko@kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
Funding Source
Organization
None
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
Institutional Review Board of Kurume University School of Medicine
Address
67 Asahi-machi, Kurume-shi, Fukuoka, Japan
Tel
0942-31-7563
i_rinri@kurume-u.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
| 2022 | Year | 07 | Month | 26 | 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
783
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
| 2018 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Items of medical information to be registered
Medical history, diagnosis, age, age at diagnosis, sex, height, weight, abdominal circumference, grip strength, body composition, family history, medical history, lifestyle history (alcohol, tobacco, etc.), treatment details, blood tests (HbA1c, blood sugar including sugar metabolism related, liver function, kidney function, lipids, thyroid function, blood count, CRP, bone metabolism markers, etc.), urine test (occult blood, protein, albumin), fecal examination (occult blood, fat), bone mineral density, tendon reflexes, vibratory perception, gait speed, neck examination, etc. protein, albumin), fecal examination (occult blood, fat), bone mineral density, cognitive function evaluation, sleep evaluation, fundus examination, tendon reflexes, vibration perception, gait speed, carotid artery echo
Management information
Registered date
| 2022 | Year | 07 | Month | 26 | Day |
Last modified on
| 2022 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055239
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
