UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022047 |
|---|---|
| Receipt number | R000025417 |
| Scientific Title | Nagoya Tokai multi center study for Japanese patients with type 1 diabetes |
| Date of disclosure of the study information | 2016/04/25 |
| Last modified on | 2023/10/31 09:18:32 |
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Basic information
Public title
Nagoya Tokai multi center study for Japanese patients with type 1 diabetes
Acronym
Tokai multi center study
Scientific Title
Nagoya Tokai multi center study for Japanese patients with type 1 diabetes
Scientific Title:Acronym
Tokai multi center study
Region
| Japan |
Condition
Condition
Type 1 Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the epidemiological data, such as clinical course, treatment, complications and diagnostic methods by collecting background information of patients with type 1 diabetes.
Basic objectives2
Others
Basic objectives -Others
Diabetic complications, autoantibody, uria protein, family history of diabetes
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change over time of HbA1c
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
Diagnosis of type 1 diabetes
Key exclusion criteria
Patients who is determined to not appropriate as this study by research investigator or research sharing doctor.
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Arima |
Organization
Nagoya University Graduate School of Medicine
Division name
Endocrinology and Diabetes
Zip code
466-0065
Address
65 Tsurumai-Cho, Showa-ku, Nagoya, Aichi
TEL
0527442142
arima105@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Onoue |
Organization
Nagoya University Hospital
Division name
Endocrinology and Diabetes
Zip code
466-0065
Address
65 Tsurumai-Cho, Showa-ku, Nagoya, Aichi
TEL
0527442142
Homepage URL
t-onoue@med.nagoya-u.ac.jp
Sponsor or person
Institute
Endocrinology and Diabetes, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self Funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Graduate School of Medicine
Address
65 Tsurumai-Cho, Showa-ku, Nagoya, Aichi
Tel
052-744-2479
ethics@med.nagoya-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
名古屋大学医学部附属病院、名古屋医療センター、名古屋第一赤十字病院、名古屋第二赤十字病院、社会保険中京病院、海南病院、安城更生病院、江南厚生病院、名鉄病院、名古屋セントラル病院、名古屋掖済会病院、中日病院、大同病院、総合上飯田第一病院、稲沢市民病院、津島市民病院、四日市市立病院、公立陶生病院、一宮市立市民病院、トヨタ記念病院、岡崎市民病院、春日井市民病院、土岐市立総合病院、岐阜県立多治見病院、岐阜社会保険病院、大垣市民病院、豊橋市民病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Following data will be collected from medical records.
Age, gender, age of onset, disease type, height, weight, drinking and smoking history, past medical history, at onset S-CPR, glucagon load 6 minutes value, 24h urine CPR, anti-GAD antibody levels, anti-IA-2 antibody value , anti-ZnT8 antibody value, HLA information, sBP, dBP, urinary albumin, BUN, s-Cr values, GOT, GPT, T-chol, TG, HDL, LDL, GA, insulin antibody titer, the presence or absence of complications, HbA1c , amount of insulin and type, family history, TSH, FreeT3, FreeT4, anti-Tg antibody value, the anti-TPO antibody values, Na, K, Cl, Ca, etc.
Management information
Registered date
| 2016 | Year | 04 | Month | 25 | Day |
Last modified on
| 2023 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025417
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
