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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031607
Receipt No. 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 2018/09/05

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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
Middle name
Last name Munehide Matuhisa
Organization Tokushima University
Division name Diabetes Therapeutics and Research Center, Institute of Advanced Medical Sciences
Zip code
Address 3-18-15, Kuramoto-cho, Tokushima
TEL 088-633-7587
Email matuhisa@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mori Hiroyasu
Organization Tokushima University
Division name Diabetes Therapeutics and Research Center, Institute of Advanced Medical Sciences
Zip code
Address 3-18-15, Kuramoto-cho, Tokushima
TEL 088-633-7587
Homepage URL
Email mori.hiroyasu@tokushima-u.ac.jp

Sponsor
Institute Tokushima University
Institute
Department

Funding Source
Organization Tokushima 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
Address
Tel
Email

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
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 No longer recruiting
Date of protocol fixation
2017 Year 05 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 01 Day
Last follow-up date
2019 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

Management information
Registered date
2018 Year 03 Month 06 Day
Last modified on
2018 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035223

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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