UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054012 |
|---|---|
| Receipt number | R000061658 |
| Scientific Title | Association between pathophysiology, metabolic disorders, lifestyle background, and diabetic complications/comorbidities in Japanese people with diabetes |
| Date of disclosure of the study information | 2024/05/01 |
| Last modified on | 2024/06/01 22:42:00 |
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Basic information
Public title
Association between pathophysiology, metabolic disorders, lifestyle background, and diabetic complications/comorbidities in Japanese people with diabetes
Acronym
Association between metabolic disorders and comorbidities in Japanese people with diabetes
Scientific Title
Association between pathophysiology, metabolic disorders, lifestyle background, and diabetic complications/comorbidities in Japanese people with diabetes
Scientific Title:Acronym
Association between metabolic disorders and comorbidities in Japanese people with diabetes
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We will determine what pathophysiology, metabolic disorders, treatments, life circumstances, or changes in these factors influence the development and progression of diabetes complications and comorbidities.
Basic objectives2
Others
Basic objectives -Others
We will examine the relationship between the pathophysiology of diabetes, metabolic disorders, treatments, lifestyle background, and diabetic complications and comorbidities.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification of factors associated with the development and progression of diabetic complications and comorbidities
Key secondary outcomes
1 Identification of factors related to improvement/remission of the diabetic complications and comorbidities
2 Identification of factors associated with the presence or absence of diabetic complications and comorbidities at baseline
3 Relationship with the diabetic complications and comorbidities by diabetes classification
4 Relationship between each diabetic complication and comorbidities
5 Identification of factors associated with changes in each metabolic disease indicator
6 Identification of factors associated with each metabolic disease indicator at baseline
7 Relationship with each metabolic disease indicator by diabetes classification
8 Relationship between each metabolic disease indicator
9 Identification of factors associated with changes in each lifestyle and satisfaction index
10 Identification of factors associated with each lifestyle and satisfaction index at baseline
11 Relationship with each lifestyle and satisfaction index by diabetes classification
12 Relationship between each lifestyle and satisfaction index
13 Diabetes-associated endocrine disorders and endocrine function in relation to the diabetic complications and comorbidities, as well as in relation to each metabolic disease indicator, lifestyle and satisfaction index
14 Relationship between ophthalmological indices including the overall characteristics of fundus photographs, characteristics of retinal blood vessels on fundus photographs, results of fundus 3D image analysis, and the diabetic complications and comorbidities, each metabolic disease indicators and lifestyle and satisfaction indices
15 Identification of factors associated with the combination of diabetes and liver fibrosis/cirrhosis
16 Association of SNPs with the diabetic complications and comorbidities, and each metabolic disease indicator
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 18 years of age or more
2 Written informed consent
Key exclusion criteria
1 Patients hospitalized
2 Pregnancy or possibly pregnant woman
3 Diabetic coma
4 Severe infection or severe trauma
5 Patients who thought to be inappropriate to enter this study for some reasons by physician's judgments
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Akinobu |
| Middle name | |
| Last name | Nakamura |
Organization
Faculty of Medicine, Graduate School of Medicine, Hokkaido University
Division name
Department of Rheumatology, Endocrinology and Nephrology
Zip code
060-8638
Address
N-15, W-7, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5915
akinbo@tim.hi-ho.ne.jp
Public contact
Name of contact person
| 1st name | Akinobu |
| Middle name | |
| Last name | Nakamura |
Organization
Faculty of Medicine, Graduate School of Medicine, Hokkaido University
Division name
Department of Rheumatology, Endocrinology and Nephrology
Zip code
060-8638
Address
N-15, W-7, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5915
Homepage URL
akinbo@tim.hi-ho.ne.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
N-14, W-5, Kita-ku, Sapporo, Hokkaido, Japan
Tel
011-706-7636
crjimu@huhp.hokudai.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
| 2024 | Year | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2033 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is an observational study.
Management information
Registered date
| 2024 | Year | 03 | Month | 29 | Day |
Last modified on
| 2024 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061658
