UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043285 |
|---|---|
| Receipt number | R000049418 |
| Scientific Title | New biomarkers for the progression of diabetic vascular complications |
| Date of disclosure of the study information | 2021/02/09 |
| Last modified on | 2022/02/10 19:25:19 |
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Basic information
Public title
New biomarkers for the progression of diabetic vascular complications
Acronym
New biomarkers for the progression of diabetic vascular complications
Scientific Title
New biomarkers for the progression of diabetic vascular complications
Scientific Title:Acronym
New biomarkers for the progression of diabetic vascular complications
Region
| Japan |
Condition
Condition
Diabetes Mellitus
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Correlation between candidate substances of new biomarker and various parameters related to diabetes and vascular complications
Basic objectives2
Others
Basic objectives -Others
Correlation between candidate substances of new biomarker and various parameters related to diabetes and vascular complications
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between candidate substances of new biomarker and various parameters related to diabetes and vascular complications
Key secondary outcomes
Renal and urethral microbiome, Biological environment that facilitates the colonization of specific microbiota
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients admitting to Mie University Hospital
2. Male or female patients 20 years or older
3. Patients who are planned to procedure blood and urine sampling for the treatment of primary disease
4. Obtained written informed consent
5. Participants in "Analysis of mechanism of insulin resistance and vascular comorbidity in diabetes mellitus and obesity"
6. Participants in "Surveillance of transition from impaired glucose intolerance to overt diabetes mellitus in Mihama Town, Minamimuro District "
Key exclusion criteria
1. The case without written informed consent
2. When the researchers determines that the case is not appropriate for the study
3. When the participants reject the registration by opt-out
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Yano |
Organization
Mie University Hospital
Division name
Department of Diabetes and Endocrinology
Zip code
514-8507
Address
2-174, Edobashi, Tsu, Mie
TEL
059-232-1111
yanoyuta@med.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Nishihama |
Organization
Mie University Hospital
Division name
Clinical training and Career Support Department
Zip code
514-8507
Address
2-174, Edobashi, Tsu, Mie
TEL
059-232-1111
Homepage URL
k-nishihama@med.mie-u.ac.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
Funding Source
Organization
Mie 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
the Clinical Research Ethics Review Committee of Mie University Hospital
Address
2-174, Edobashi, Tsu, Mie
Tel
059-231-5634
kk-sien@mo.medic.mie-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
| 2021 | Year | 02 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluate the correlation between various parameters and the concentration of biomarker candidate substances, and its variation over time.
Management information
Registered date
| 2021 | Year | 02 | Month | 09 | Day |
Last modified on
| 2022 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049418
