UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050610 |
|---|---|
| Receipt number | R000057649 |
| Scientific Title | The effect of team-based medical care on kidney function in patients with diabetic nephropathy |
| Date of disclosure of the study information | 2023/03/31 |
| Last modified on | 2023/03/16 18:48:43 |
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Basic information
Public title
The effect of team-based medical care on kidney function in patients with diabetic nephropathy
Acronym
The effect of team-based medical care on kidney function in patients with diabetic nephropathy
Scientific Title
The effect of team-based medical care on kidney function in patients with diabetic nephropathy
Scientific Title:Acronym
The effect of team-based medical care on kidney function in patients with diabetic nephropathy
Region
| Japan |
Condition
Condition
diabetic nephropathy
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will evaluate the effect of multidisciplinary team care on kidney function in patients with diabetic nephropathy who receive instruction to prevent dialysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
eGFR
Key secondary outcomes
blood glucose level
HbA1c
Proteinuria
Presumptive salt-intake
meal
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
1)Patients with type 2 diabetes
2)Patients with diabetic nephropathy stage 2,3 and 4
3)Patients whose urine albumin level more than 30mg/gCr or eGFR below 60ml/min/1.73m2
4)Patients who give informed consent
Key exclusion criteria
1)Patients with type 1 diabetes
2)Patients with malignancy upon enrollment of the trial
3)Patients with pregnancy upon enrollment of the trial
4)Patients who did not agree to participate in this clinical trial
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kosuke |
| Middle name | |
| Last name | Shima |
Organization
Kouseiren Takaoka Hospital
Division name
Department of Diabetes,Endocrinology and Metabolism
Zip code
933-8555
Address
5-10 Eirakumachi,Takaoka-city, Toyama,Japan
TEL
0766-21-3930
shimaccyo@gmail.com
Public contact
Name of contact person
| 1st name | Mayumi |
| Middle name | |
| Last name | Kiku |
Organization
Kouseiren Takaoka Hospital
Division name
Department of Nutritional management
Zip code
933-8555
Address
5-10 Eirakumachi,Takaoka-city, Toyama,Japan
TEL
0766-21-3930
Homepage URL
mk1amechan@gmail.com
Sponsor or person
Institute
Kouseiren Takaoka Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Kouseiren Takaoka Hospital Institutional Review Board
Address
5-10 Eirakumachi,Takaoka-city,Toyama,Japan
Tel
0766-21-3930
mk1amechan@gmail.com
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
厚生連高岡病院(富山県)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 31 | 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
| 2022 | Year | 12 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective cohort study.
Management information
Registered date
| 2023 | Year | 03 | Month | 16 | Day |
Last modified on
| 2023 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057649
