UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037527 |
|---|---|
| Receipt number | R000042779 |
| Scientific Title | Investigational research of gut microbiome associated with hypertensive patients |
| Date of disclosure of the study information | 2019/09/30 |
| Last modified on | 2023/01/30 10:24:45 |
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Basic information
Public title
Investigational research of gut microbiome associated with hypertensive patients
Acronym
GMH
Scientific Title
Investigational research of gut microbiome associated with hypertensive patients
Scientific Title:Acronym
GMH
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Reveal intestinal flora specific to hypertensive patients
Basic objectives2
Others
Basic objectives -Others
To clarify the difference of intestinal flora due to obesity and salt intake
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of intestinal flora of control group (concurrently, non-hypertensive person) and hypertensive patient
Key secondary outcomes
Comparison of intestinal flora with obesity and salt intake
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Nutrition instruction
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
high blood pressure (office systolic blood pressure more than 140 or/and diastolic blood pressure more than 90 mmHg or taking antihypertensive drugs)
Key exclusion criteria
Patients who are pregnant or nursing
Person who meets overt diabetes (fasting blood glucose 126 mg / dl or more, blood glucose 200 mg / dl or more, HbA1c 6.5% or more, or taking antidiabetic medication)
Person with severe organ damages (cerebral infarction, cerebral hemorrhage, chronic kidney disease stage 4 or more: eGFR <30, heart failure etc)
Those who participate in other clinical research
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Arakawa |
| Middle name | |
| Last name | Kimika |
Organization
National Hospital Organization Kyushu Medical Center
Division name
Department of Clinical Laboratory
Zip code
8108563
Address
1-8-1 Jigyohama, Chuo-ku, Fukuoka, Japan
TEL
092-852-0700
arakawa.kimika.rp@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Kimika |
| Middle name | |
| Last name | Arakawa |
Organization
National Hospital Organization Kyushu Medical Center
Division name
Department of Clinical Laboratory
Zip code
8108563
Address
1-8-1 Jigyohama, Chuo-ku, Fukuoka, Japan
TEL
092-852-0700
Homepage URL
arakawa.kimika.rp@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Kyushu Medical Center, Department of Clinical Laboratory
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Kyushu Medical Center, Clinical trial support center
Address
1-8-1 Jigyohama, Chuo-ku, Fukuoka, Japan
Tel
092-852-0700
602-rinri@mail.hosp.go.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
| 2019 | Year | 09 | Month | 30 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2019 | Year | 07 | Month | 29 | Day |
Last modified on
| 2023 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042779
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
