UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045588 |
|---|---|
| Receipt number | R000050494 |
| Scientific Title | The long term effect of moderately low-carbohydrate diet on DKD patients with eGFR<45ml/min/1.73m2 |
| Date of disclosure of the study information | 2021/09/28 |
| Last modified on | 2021/09/28 12:54:34 |
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Basic information
Public title
The long term effect of moderately low-carbohydrate diet on DKD patients with eGFR<45ml/min/1.73m2
Acronym
The long term effect of moderately low-carbohydrate diet on DKD patients with eGFR<45ml/min/1.73m2
Scientific Title
The long term effect of moderately low-carbohydrate diet on DKD patients with eGFR<45ml/min/1.73m2
Scientific Title:Acronym
The long term effect of moderately low-carbohydrate diet on DKD patients with eGFR<45ml/min/1.73m2
Region
| Japan |
Condition
Condition
Diabetic nephropathy stage4
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the change of eGFR in DKD patients with eGFR<45ml/min/1.73m2 who have educated moderately low-carbohydrate without protein restriction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
eGFR decline
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with diabetes and eGFR<45ml/min/1.73m2
Key exclusion criteria
Patients with hemodialysis
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yamada |
| Middle name | |
| Last name | Satoru |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Diabate Center
Zip code
108-0072
Address
5-9-1 Shirogane,Minato-ku
TEL
03-3444-6161
yamada-s@insti.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Yamada |
| Middle name | |
| Last name | Satoru |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Diabate Center
Zip code
108-0072
Address
5-9-1 Shirogane,Minato-ku
TEL
03-3444-6161
Homepage URL
yamada-s@insti.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University Kitasato Institute Hospital
Institute
Department
Personal name
Funding Source
Organization
Kitasato Institute Hospital
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
Kitasato Institute Hospital
Address
5-9-1 Shirogane,Minato-ku
Tel
03-3444-6161
kenkyu@insti.kitasato-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 | 09 | Month | 28 | 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
| 2020 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 01 | Month | 13 | 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
none
Management information
Registered date
| 2021 | Year | 09 | Month | 28 | Day |
Last modified on
| 2021 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050494
