UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023612 |
|---|---|
| Receipt number | R000027191 |
| Scientific Title | Japanese Type 1 diabetes data-basE |
| Date of disclosure of the study information | 2016/08/12 |
| Last modified on | 2016/08/12 21:52:11 |
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Basic information
Public title
Japanese Type 1 diabetes data-basE
Acronym
TIDE-J
Scientific Title
Japanese Type 1 diabetes data-basE
Scientific Title:Acronym
TIDE-J
Region
| Japan |
Condition
Condition
Type 1 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Japanese type 1 diabetes is classified into 3 subclasses: acute-onset type 1 diabetes, fulminant type 1 diabetes and slowly progressive type 1 diabetes. Our aim is to establish the comprehensive database of genomic and clinical information based on sub-classification of type 1 diabetes and to apply the database for development of new diagnostic markers, elucidation of etiological mechanism, prediction of type 1 diabetes and investigation of optimal treatments.
Basic objectives2
Others
Basic objectives -Others
To clarify the genomic and clinical characteristics of 3 subclasses of Japanese type 1 diabetes.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1)To clarify the natural histories of 3 subclasses of Japanese type 1 diabetes and to establish the genomic and serum library as the basal data for intervention studie.
2)To analyze the integrated information of the genetic data and longitudinal clinical and biochemical data based on the established database.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with type 1 diabetes meeting the criteria shown as below.
1) Less than 5 years after the onset of diabetes
2) Positive for any pancreatic islet related autoantibodies and/or less than 1.0 ng/ml of C-peptide in fasting serum at diagnosis
Key exclusion criteria
Not applicable
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kajio |
Organization
National Center for Global Health and Medicine Hospital
Division name
Department of Diabetes, Endocrinology and Metabolism
Zip code
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan
TEL
+81-3-3202-7181
hkajio@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kajio |
Organization
National Center for Global Health and Medicine Hospital
Division name
Department of Diabetes, Endocrinology and Metabolism
Zip code
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan
TEL
+81-3-3202-7181
Homepage URL
hkajio@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
国立国際医療研究センター（東京都、千葉県）、大阪医科大学（大阪府）、山梨大学（山梨県）、近畿大学（大阪府）、大阪大学（大阪府）、埼玉医科大学（埼玉県）、愛媛大学（愛媛県）、長崎大学（長崎県）、新古賀病院（福岡県）、岩手医科大学（岩手県）、済生会中央病院（東京都）、神戸大学（兵庫県）、冲中記念成人病研究所（東京都）、岩手県立大学（岩手県）、昭和大学（東京都）、国際医療福祉大学（栃木県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
At 59th scientific annual meeting of Japan Diabetes Society, we gave a tentative report on the characteristics of insulin secretion, pancreatic islet related autoantibidies and genome in 3 subclasses of Japanese type 1 diabetes based on the data from the subjects recruited until then.
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
| 2010 | Year | 12 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 11 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Clinical check and blood sampling are performed regularly once a year. Genome sampling is performed at entry.
1) Check points at entry
Back ground: age at onset, sex, body length, body weight, blood pressure, duration of diabetes, family history, past history, diabetic complications (retinopathy, nephropathy, neuropathy), symptoms at onset, accompany of other autoimmune diseases, pregnancy before onset of diabetes, signs of abdominal abnormalities (abdominal echogram, abdominal CT, MRI), sign of pancreatic abnormality, blood gas analysis at onset, parameters of carbohydrate metabolism: plasma glucose level, HbA1c(NGSP), glycoalbumin, urine ketone body, serum ketone body, parameters of insulin secretion: fasting blood C-peptide level, exocrine pancreatic enzymes (amylase, elastase 1, lipase), islet associated autoantibodies (anti-GAD antibody, anti-IA-2 antibody, IAA(within 2 weeks after beginning of treatment), anti-ZnT8 antibody, thyroid associated autoantibodies (anti-thyroglobulin antibody, anti-TPO antibody, anti-TSH receptor antibody), HLA typing (A, B, C, DRB1-DQA1-DQB1), other genetic analyses (insulin, CTLA4, PTPN22, IL2RA, SUMO-4, vitamin D receptor and et al.), treatment, insulin for one day (dose, types, frequency), type of type 1 diabetes, classification of type 1 diabetes (day at diagnosis)
2) Check points (every year)
body length, body weight, blood pressure, diabetic complications (retinopathy, nephropathy, neuropathy) , parameters of carbohydrate metabolism: plasma glucose level, HbA1c(NGSP), parameters of insulin secretion: fasting blood C-peptide level (5ml serum at fasting is preserved), islet associated autoantibodies (anti-GAD antibody, anti-IA-2 antibody), treatment, insulin for one day (dose, types, frequency), medicines used with insulin
Management information
Registered date
| 2016 | Year | 08 | Month | 12 | Day |
Last modified on
| 2016 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027191
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