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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042241
Receipt No. R000048211
Scientific Title Study of the prevalence of celiac disease in patients with T1DM in our hospital
Date of disclosure of the study information 2020/11/01
Last modified on 2020/10/26

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Basic information
Public title Study of the prevalence of celiac disease in patients with T1DM in our hospital
Acronym Prevalence of celiac disease in patients with T1DM
Scientific Title Study of the prevalence of celiac disease in patients with T1DM in our hospital
Scientific Title:Acronym Prevalence of celiac disease in patients with T1DM
Region
Japan

Condition
Condition celiac disease
Classification by specialty
Gastroenterology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to reveal the prevalence of celiac disease in patients with T1DM in our hospital
Basic objectives2 Others
Basic objectives -Others to reveal the clinical background of the patients with both T1DM and celiac disease
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes anti-tissue transglutaminase IgA antibody
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 patients with T1DM treated in our hospital
Key exclusion criteria nothing
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Takeshi
Middle name
Last name Ohara
Organization Hyogo Brain and Heart Center, Himeji, Hyogo, Japan
Division name Department of Diabetes and Endocrinology
Zip code 670-0981
Address 520, Saisho-Kou, Himeji, Hyogo,670-0981, Japan
TEL 079-293-3131
Email oohara@hp.pref.hyogo.jp

Public contact
Name of contact person
1st name Takeshi
Middle name
Last name Ohara
Organization Hyogo Brain and Heart Center, Himeji, Hyogo, Japan
Division name Department of Diabetes and Endocrinology
Zip code 670-0981
Address 520, Saisho-Kou, Himeji, Hyogo,670-0981, Japan
TEL 079-293-3131
Homepage URL
Email oohara@hp.pref.hyogo.jp

Sponsor
Institute Hyogo Brain and Heart Center, Himeji, Hyogo, Japan
Institute
Department

Funding Source
Organization Shimane University School of Medicine
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor Shimane University School of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hyogo Brain and Heart Center, Himeji, Hyogo, Japan
Address 520, Saisho-Kou, Himeji, Hyogo,670-0981, Japan
Tel 0792933131
Email oohara@hp.pref.hyogo.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 Preinitiation
Date of protocol fixation
2020 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 11 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective study

Management information
Registered date
2020 Year 10 Month 26 Day
Last modified on
2020 Year 10 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048211

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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