UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031607 |
|---|---|
| Receipt number | R000035223 |
| Scientific Title | The influence of impaired salty taste thresholds and salt intake on annual decline of eGFR in patients with diabetes |
| Date of disclosure of the study information | 2018/03/10 |
| Last modified on | 2022/10/25 15:10:10 |
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Basic information
Public title
The influence of impaired salty taste thresholds and salt intake on annual decline of eGFR in patients with diabetes
Acronym
The impact of salty taste thresholds and salt intake on diabetic nephropathy
Scientific Title
The influence of impaired salty taste thresholds and salt intake on annual decline of eGFR in patients with diabetes
Scientific Title:Acronym
The impact of salty taste thresholds and salt intake on diabetic nephropathy
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the influence of estimated daily salt intake and salt taste thresholds on the decline of renal function in patients with diabetes. We also investigate the risk factors, such as diet, exercise and life style, which might influence on the decline of renal function.
Basic objectives2
Others
Basic objectives -Others
Research for the risk factors, which will cause renal dysfunction
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate diet, exercise and life style, which might influence on the annual decline of renal function. We also evaluate clinical examinations below to find out the correlation between these variables and the decline of the renal function.
eGFR, urinary albumin/ creatinine ratio, urinary liver-type fatty acid-binding protein, urinary N-acetyl-beta-D-glucosaminidase, urinary beta2-Microgrobulin, urinary adiponectin
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
1. Patients with type 1 and type 2 diabetes
2. Patients who signed the agreement with this study
Key exclusion criteria
1. Patients with remarkable dysgeusia
2. Gestational diabetes mellitus and specific types of diabetes due to other causes
3. Patients with kidney disease, which is not associated with diabetes
4. Patients who are considered inappropriate by the attendant physician
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Munehide |
| Middle name | |
| Last name | Matuhisa |
Organization
Tokushima University
Division name
Diabetes Therapeutics and Research Center, Institute of Advanced Medical Sciences
Zip code
770-8503
Address
3-18-15, Kuramoto-cho, Tokushima
TEL
088-633-7587
matuhisa@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Mori |
Organization
Tokushima University
Division name
Diabetes Therapeutics and Research Center, Institute of Advanced Medical Sciences
Zip code
770-8503
Address
3-18-15, Kuramoto-cho, Tokushima
TEL
088-633-7587
Homepage URL
mori.hiroyasu@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Sysmex
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
Tokushima University
Address
3-18-15, Kuramoto-cho, Tokushima
Tel
0886337587
mori.hiroyasu@tokushima-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
| 2018 | Year | 03 | Month | 10 | 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
250
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
Main results already published
Date of protocol fixation
| 2017 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
on going by March 2022
Management information
Registered date
| 2018 | Year | 03 | Month | 06 | Day |
Last modified on
| 2022 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035223
