UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016243 |
|---|---|
| Receipt number | R000016685 |
| Scientific Title | The effects of dietary salt restriction on blood pressure variability of ABPM: 7 Days ABPM and CGM Study |
| Date of disclosure of the study information | 2015/01/17 |
| Last modified on | 2015/04/17 14:46:33 |
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Basic information
Public title
The effects of dietary salt restriction on blood pressure variability of ABPM: 7 Days ABPM and CGM Study
Acronym
7DACS
Scientific Title
The effects of dietary salt restriction on blood pressure variability of ABPM: 7 Days ABPM and CGM Study
Scientific Title:Acronym
7DACS
Region
| Japan |
Condition
Condition
Hypertensive patient with type 2 diabetes
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate how rigorous salt restriction may help improve short-term blood pressure variability and circadian rhythm of blood pressure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
reduced short-term blood pressure variability or normalized circadian rhythm of blood pressure
Key secondary outcomes
improvements of sodium excretion, body weight, or blood glucose
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
hypertensive patients with type 2 diabetes not receiving antihypertensive agents
Key exclusion criteria
type 1 diabetes, secondary diabetes, diabetic ketoacidosis, advanced dehydration, advanced renal impairment, advanced hepatic impairment, evidence of CVD, malignancy, or if they were pregnant
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Iuchi |
Organization
Jikei University School of Medicine
Division name
Division of Diabetes, Metabolism and Endocrinology
Zip code
Address
3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo
TEL
03-3433-1111
h-iuchi@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Iuchi |
Organization
Jikei University School of Medicine
Division name
Division of Diabetes, Metabolism and Endocrinology
Zip code
Address
3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo
TEL
03-3433-1111
Homepage URL
h-iuchi@jikei.ac.jp
Sponsor or person
Institute
Division of Diabetes, Metabolism and Endocrinology, Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Diabetes, Metabolism and Endocrinology, Jikei University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 01 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2013 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 17 | Day |
Last modified on
| 2015 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016685
