UMIN-CTR Clinical Trial

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
Email	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
Email	mori.hiroyasu@tokushima-u.ac.jp

Sponsor
Institute	Tokushima University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035223