UMIN-CTR Clinical Trial

Basic information
Public title	Effect of sodium restriction education by physician in type 2 diabetes patients with excessive salt intake
Acronym	Effect of sodium restriction educationin type 2 diabetes patients
Scientific Title	Effect of sodium restriction education by physician in type 2 diabetes patients with excessive salt intake
Scientific Title:Acronym	Effect of sodium restriction educationin type 2 diabetes patients
Region	Japan

Condition
Condition	type 2 diabetes, hypertension
Classification by specialty	Cardiology Endocrinology and Metabolism Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to assume the advantage in randomization comparison between intervention group and control grou clinical on effect of sodium restriction education by physician among type2 diabetes.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	sodium intake, urine Na/K, home blood pressure data
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Participants in the intervention group receive salt-restriction education approximately 10 minutes by physician.
Interventions/Control_2	No education
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patient with type 2 diabetes 2) Age;20-89 years old 3) Salt intake; Patient without hypertension; men:equal to or more than 8.0g femaleequal to or more than 7.0g Patient with hypertension; equal to or more than 6g
Key exclusion criteria	1) Advanced renal dysfunction (serum creatinine:equal to or more than 2.0 mg/dl) 2) severe cardiovascular and cerebrovasculardisease 3) pregnant/lactating
Target sample size	400

Research contact person
Last name of lead principal investigator	1st name Michiaki Middle name Last name Fukui
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Endocrinology and Metabolism
Zip code	602-8566
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL	075-251-5506
Email	sayarinapm@hotmail.com

Public contact
1st name of contact person	1st name Michiaki Middle name Last name Fukui
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Endocrinology and Metabolism
Zip code	602-8566
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL	075-251-5506
Homepage URL
Email	sayarinapm@hotmail.com

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	Kyoto Prefectural University of Medicine
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	Kyoto Prefectural University of Medicine
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
Tel	075-251-5111
Email	m-muramatsu76@pref.kyoto.lg.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	2017 Year 08 Month 24 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	Open public recruiting
Date of protocol fixation	2016 Year 01 Month 01 Day
Date of IRB	2016 Year 03 Month 01 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 08 Month 24 Day
Last modified on	2019 Year 03 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026346