UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028809 |
|---|---|
| Receipt number | 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 12:09:14 |
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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
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
sayarinapm@hotmail.com
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026346
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
