UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000016846
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email harry@jikei.ac.jp

Sponsor
Institute Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019538

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.