UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048471 |
|---|---|
| Receipt number | R000055242 |
| Scientific Title | Establishment and analysis of Diabetes Registry in Chikugo |
| Date of disclosure of the study information | 2022/07/26 |
| Last modified on | 2022/07/26 18:18:12 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Establishment and analysis of Diabetes Registry in Chikugo
Acronym
Establishment and analysis of Diabetes Registry in Chikugo
Scientific Title
Establishment and analysis of Diabetes Registry in Chikugo
Scientific Title:Acronym
Establishment and analysis of Diabetes Registry in Chikugo
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 of patients with diabetes mellitus and to identify effective diabetes treatments.
Basic objectives2
Others
Basic objectives -Others
To elucidate the specific and effective target to help treating the patients with DM in this region.
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
The research subjects must be registered in the "Registry of Diabetes Patients in Chikugo Area" (Kurume University IRB, Research No. 18053) by attending or being hospitalized between June 2018 and June 2019 at the Department of Endocrinology and Metabolism, Kurume University, and at the collaborating research institutions.
Key exclusion criteria
Research subjects who have requested to opt out of the study.
Those who do not agree to participate in this study.
Target sample size
783
Research contact person
Name of lead principal investigator
| 1st name | Mizuki |
| Middle name | |
| Last name | Gobaru |
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
goubaru_miduki@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Mizuki |
| Middle name | |
| Last name | Gobaru |
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
goubaru_miduki@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
Funding Source
Organization
self-financing
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2027 | Year | 04 | 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=R000055242
