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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028809
Receipt No. R000026346
Scientific Title Effect of sodium restriction education by physician in type 2 diabetes patients with excessive salt intake
Date of disclosure of the study information 2017/08/24
Last modified on 2019/03/23

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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
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
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/ctr_e/ctr_view.cgi?recptno=R000026346

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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