UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046849 |
|---|---|
| Receipt number | R000053378 |
| Scientific Title | Evaluation of the risk factors for diabetic complications in Japanese patients with type 1 diabetes mellitus |
| Date of disclosure of the study information | 2022/02/17 |
| Last modified on | 2025/02/03 22:55:59 |
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Basic information
Public title
Evaluation of the risk factors for diabetic complications in Japanese patients with type 1 diabetes mellitus
Acronym
Evaluation of the risk factors for diabetic complications in Japanese patients with type 1 diabetes mellitus
Scientific Title
Evaluation of the risk factors for diabetic complications in Japanese patients with type 1 diabetes mellitus
Scientific Title:Acronym
Evaluation of the risk factors for diabetic complications in Japanese patients with type 1 diabetes mellitus
Region
| Japan |
Condition
Condition
type 1 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify risk factors for diabetic complications in Japanese patients with type 1 diabetes mellitus
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Risk factors for diabetic complications
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with type 1 diabetes mellitus aged between 20 and 80
Key exclusion criteria
1. In the perioperative period or with a serious infection or injury.
2. Post pancreas transplantation.
3. Using steroids orally or intravenously.
4. Other ineligibility determined by an investigator.
Target sample size
418
Research contact person
Name of lead principal investigator
| 1st name | Naoto |
| Middle name | |
| Last name | Katakami |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Metabolic Medicine
Zip code
565-0871
Address
2-2 Yamadaoka, Suita City, Osaka
TEL
06-6879-3732
katakami@endmet.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Takafumi |
| Middle name | |
| Last name | Masuda |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Metabolic Medicine
Zip code
565-0871
Address
2-2 Yamadaoka, Suita City, Osaka
TEL
06-6879-3732
Homepage URL
t-masuda@endmet.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Osaka 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
Osaka University Hospital
Address
2-2 Yamadaoka, Suita City, Osaka
Tel
06-6879-5111
rinri@hp-crc.med.osaka-u.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
| 2022 | Year | 02 | Month | 17 | 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
226
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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 18 | 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
Study design
Cross-sectional and longitudinal study
Criteria
Inpatients or outpatients who meet the eligibility criteria
Management information
Registered date
| 2022 | Year | 02 | Month | 07 | Day |
Last modified on
| 2025 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053378
