UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016846 |
|---|---|
| Receipt number | R000019538 |
| Scientific Title | Gene expression of renin-angiotensin-system components in human leukocytes study |
| Date of disclosure of the study information | 2015/03/19 |
| Last modified on | 2019/03/27 12:02:59 |
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Basic information
Public title
Gene expression of renin-angiotensin-system components in human leukocytes study
Acronym
Gene expression of renin-angiotensin-system components in human leukocytes study(GIRASOLE study)
Scientific Title
Gene expression of renin-angiotensin-system components in human leukocytes study
Scientific Title:Acronym
Gene expression of renin-angiotensin-system components in human leukocytes study(GIRASOLE study)
Region
| Japan |
Condition
Condition
Patients with chronic kidney disease, hypertension, diabetes mellitus, dyslipidemia, obesity and healthy volunteer.
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To determine the relationship between the prevalence of non-communicating disease and the expression of renin-angiotensin-system components in human leukocytes.
Basic objectives2
Others
Basic objectives -Others
To determine the clinical significance of the novel test for measurement of RAS components in leukocyte.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The prevalence of non-communicating disease, including chronic kidney disease, hypertension, diabetes mellitus, and obesity.
Key secondary outcomes
The progression to the end-stage renal disease, 50% reduction in eGFR, and all-cause mortality.
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
i)Outpatients or hospitalized patients in the Yokohama City University Hospital, consenting for study paticipation. ii)staffs and medical students of the Yokohama City University, consenting for study paticipation.
Key exclusion criteria
Patinets i)who were 19 years-old or younger, ii)having corticosteroids or immunosuppressive medications within 3 month, iii)with hematological disorder, iv)with active infection, and v)that physician judged to be inappropriate.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kouichi Tamura |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Medical Science and Cardiorenal Medicine
Zip code
Address
3-9 Fukuura, Kanazawa-ku Yokohama 236-0004, Japan
TEL
045-787-2800
tamukou@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kotaro Haruhara |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Medical Science and Cardiorenal Medicine
Zip code
Address
3-9 Fukuura, Kanazawa-ku Yokohama 236-0004, Japan
TEL
045-787-2800
Homepage URL
harry@jikei.ac.jp
Sponsor or person
Institute
Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Division of Nephrology and Hypertension, Department of Internal Medicine,
The Jikei University School of Medicine
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 | 03 | Month | 19 | Day |
Related information
URL releasing protocol
https://www.atherosclerosis-journal.com/article/S0021-9150(18)30013-3/fulltext
Publication of results
Published
Result
URL related to results and publications
https://www.atherosclerosis-journal.com/article/S0021-9150(18)30013-3/fulltext
Number of participants that the trial has enrolled
86
Results
We have obteined blood sample from 86 outpatients and 23 healthy volunteer.
The leukocyte expression of ATRAP was positively correlated with the leukocyte count, serum CRP and leukocyte imflammatory cytokine expression in these outpatients.
Results date posted
| 2019 | Year | 03 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who visited the outpatient
clinic at Yokohama City University Hospital, Yokohama, Japan.
Participant flow
Outpatient physicians and researchers explained the research to the candidate of this study at the time of outpatient clinic visit. The participant decided to join the study based on their free will.
Adverse events
None
Outcome measures
Clinical information was obtained from the data collected at a single visit to our outpatient clinic.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 04 | Month | 28 | Day |
Other
Other related information
We have started the study on April 1,2015.
Management information
Registered date
| 2015 | Year | 03 | Month | 19 | Day |
Last modified on
| 2019 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019538
