UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Japanese Type 1 diabetes data-basE
Title of the study (Brief title)	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	Hiroshi Kajio
Organization	National Center for Global Health and Medicine Hospital
Division name	Department of Diabetes, Endocrinology and Metabolism
Address	1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan
TEL	+81-3-3202-7181
Email	hkajio@hosp.ncgm.go.jp

Public contact
Name of contact person	Hiroshi Kajio
Organization	National Center for Global Health and Medicine Hospital
Division name	Department of Diabetes, Endocrinology and Metabolism
Address	1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan
TEL	+81-3-3202-7181
Homepage URL
Email	hkajio@hosp.ncgm.go.jp

Sponsor
Institute	National Center for Global Health and Medicine
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2010 Year 12 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027191