UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050703 |
|---|---|
| Receipt number | R000057759 |
| Scientific Title | Investigation of the multifaceted effect of the realistic low salt diet against the patients with hypertension and type 2 diabetes. |
| Date of disclosure of the study information | 2023/06/01 |
| Last modified on | 2024/03/28 17:25:32 |
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Basic information
Public title
Investigation of the multifaceted effect of the realistic low salt diet against the patients with hypertension and type 2 diabetes.
Acronym
Investigation of the multifaceted effect of the realistic low salt diet against the patients with hypertension and type 2 diabetes.
Scientific Title
Investigation of the multifaceted effect of the realistic low salt diet against the patients with hypertension and type 2 diabetes.
Scientific Title:Acronym
Investigation of the realistic low salt diet against the patients with hypertension and type 2 diabetes.
Region
| Japan |
Condition
Condition
Hypertension and type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A purpose of this study is to clarify the multifaceted effect of the low salt diet that is thought to easy for carrying out and continuation against for the patients with hypertension and type 2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mean blood pressure, mean day and night blood pressure, and standard deviation measured by 24-hour ambulatory blood pressure monitoring
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Various low salt seasonings will be used for usual cooking in place of normal seasonings.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients with type 2 diabetes and hypertension who has a home sphygmomanometer.
Key exclusion criteria
1. The patients with severe diabetic neuropathy
2. The patients with severe visual dysorder
3. The patients with hemodialysis
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Ueno |
Organization
Faculty of Internal Medicine, University of Miyazaki,
Division name
Division of Hematology, Diabetes, and Endocrinology, Department of Internal Medicine,
Zip code
889-1692
Address
5200, Kihara , Kiyotake, Miyazaki, Japan
TEL
-81-985-85-9121
intron@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Ueno |
Organization
Faculty of Internal Medicine, University of Miyazaki,
Division name
Division of Hematology, Diabetes, and Endocrinology, Department of Internal Medicine,
Zip code
889-1692
Address
5200, Kihara , Kiyotake, Miyazaki, Japan
TEL
-81-985-85-9121
Homepage URL
intron@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Miyazaki University
Institute
Department
Personal name
Funding Source
Organization
Miyazaki University
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
Miyazaki University
Address
5200, Kihara , Kiyotake, Miyazaki, Japan
Tel
+81-985-85-1510
rinken@med.miyazaki-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
| 2023 | Year | 06 | Month | 01 | 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
| 2023 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2023 | Year | 03 | Month | 28 | Day |
Last modified on
| 2024 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057759
| 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 |
