UMIN-CTR Clinical Trial

Basic information
Public title	Diabetes Study from the Center of Tokyo Women's Medical University
Acronym	DIACET
Scientific Title	Diabetes Study from the Center of Tokyo Women's Medical University
Scientific Title:Acronym	DIACET
Region	Japan

Condition
Condition	Patients with diabetes and impaired glucose tolerance
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucidate the pathogenesis and prognosis of Japanese patients with diabetes and impaired glucose tolerance
Basic objectives2	Others
Basic objectives -Others	To elucidate factors associated with the pathogenesis, complications and prognosis of Japanese patients with diabetes and impaired glucose tolerance
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Complications associated with diabetes and mortality
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	1 years-old <=
Age-upper limit	120 years-old >=
Gender	Male and Female
Key inclusion criteria	Japanese patients with diabetes or impaired glucose tolerance
Key exclusion criteria	Individuals from foreign countries
Target sample size	50000

Research contact person
Name of lead principal investigator	1st name Tetsuya Middle name Last name Babazono
Organization	Tokyo Women's Medical University
Division name	Diabetes Center
Zip code	1628666
Address	8-1 Kawada-cho Shinjuku-ku Tokyo, Japan
TEL	0333538111
Email	babazono.dmc@twmu.ac.jp

Public contact
Name of contact person	1st name Tetsuya Middle name Last name Babazono
Organization	Tokyo Women's Medical University School of Medicine
Division name	Diabetes Center
Zip code	162-8666
Address	8-1 Kawada-cho Shinjuku-ku Tokyo, Japan
TEL	0333538111
Homepage URL
Email	babazono@gmail.com

Sponsor
Institute	Tokyo Women's Medical University
Institute
Department

Funding Source
Organization	Tokyo Women's Medical University
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	Tokyo Women's Medical University
Address	8-1 Kawada-cho Shinjuku-ku Tokyo, Japan
Tel	0333538111
Email	rinri.bm@twmu.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	2020 Year 11 Month 01 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	Open public recruiting
Date of protocol fixation	1999 Year 01 Month 01 Day
Date of IRB	1999 Year 01 Month 01 Day
Anticipated trial start date	2002 Year 01 Month 01 Day
Last follow-up date	2030 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	questionnaires, physical and laboratory examinations

Management information
Registered date	2020 Year 10 Month 31 Day
Last modified on	2020 Year 10 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048297