UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042241 |
|---|---|
| Receipt number | 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 | 2023/05/01 17:44:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 Prefectural Harima-Himeji General Medical Center
Division name
Department of Diabetes and Endocrinology
Zip code
670-8560
Address
264-3, Kamiya-cho, Himeji, Hyogo
TEL
079-289-5080
yuki29n29@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Ohara |
Organization
Hyogo Prefectural Harima-Himeji General Medical Center
Division name
Department of Diabetes and Endocrinology
Zip code
670-8560
Address
264-3, Kamiya-cho, Himeji, Hyogo
TEL
079-289-5080
Homepage URL
oohara@hp.pref.hyogo.jp
Sponsor or person
Institute
Hyogo Prefectural Harima-Himeji General Medical Center
Institute
Department
Personal name
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 Prefectural Harima-Himeji General Medical Center
Address
264-3, Kamiya-cho, Himeji, Hyogo
Tel
079-289-5080
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
115
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
Completed
Date of protocol fixation
| 2020 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 10 | Day |
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
| 2023 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.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 |
