UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000053925
Receipt number R000061554
Scientific Title Relationships between muscle sympathetic nerve activity and serum level of fatty acid binding protein 4
Date of disclosure of the study information 2024/03/21
Last modified on 2024/03/21 14:43:59

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Basic information

Public title

Relationships between muscle sympathetic nerve activity and serum level of fatty acid binding protein 4

Acronym

Relationships between muscle sympathetic nerve activity and serum level of fatty acid binding protein 4

Scientific Title

Relationships between muscle sympathetic nerve activity and serum level of fatty acid binding protein 4

Scientific Title:Acronym

Relationships between muscle sympathetic nerve activity and serum level of fatty acid binding protein 4

Region

Japan


Condition

Condition

Healthy,Hypertension

Classification by specialty

Medicine in general Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In this study, we examinated about correlation between Muscle sympathetic nerve activity and Adipocyte Fatty Acid Binding Protein

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Adipocyte Fatty Acid Binding Protein, MSNA

Key secondary outcomes



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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

Healthy or hypertensive subjects

Key exclusion criteria

Patients with an estimated glomerular filtration rate of <50ml/min/1.73m2, advanced lung disease, mental illness, severe hepatic dysfunction, severe diabetes, neurological disease, maintenance dialysis.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Tadayuki
Middle name
Last name Hirai

Organization

Kanazawa University Graduate School of Medical Sciences

Division name

Department of Cardiovascular Medicine

Zip code

9208641

Address

13 -1 Takaramachi, Kanazawa-city, Ishikawa

TEL

+81-76-265-2000

Email

thiraikz@gmail.com


Public contact

Name of contact person

1st name Tadayuki
Middle name
Last name Hirai

Organization

Kanazawa University Graduate School of Medical Sciences

Division name

Department of Cardiovascular Medicine

Zip code

9208641

Address

13 -1 Takaramachi, Kanazawa-city, Ishikawa

TEL

+81-76-265-2000

Homepage URL


Email

thiraikz@gmail.com


Sponsor or person

Institute

Kanazawa University

Institute

Department

Personal name



Funding Source

Organization

Otsuka Medical Devices Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nothing

Address

Nothing

Tel

Nothing

Email

Nothing


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

2024 Year 03 Month 21 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

Enrolling by invitation

Date of protocol fixation

2020 Year 03 Month 03 Day

Date of IRB

2020 Year 05 Month 25 Day

Anticipated trial start date

2020 Year 05 Month 25 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

I have finished observing 20 cases.


Management information

Registered date

2024 Year 03 Month 21 Day

Last modified on

2024 Year 03 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061554


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name