UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029135
Receipt number R000033312
Scientific Title Endothelial Disorder in Lifestyle-related diseases
Date of disclosure of the study information 2017/11/01
Last modified on 2020/03/03 22:20:30

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Basic information

Public title

Endothelial Disorder in Lifestyle-related diseases

Acronym

Endothelial Disorder in Lifestyle-related diseases

Scientific Title

Endothelial Disorder in Lifestyle-related diseases

Scientific Title:Acronym

Endothelial Disorder in Lifestyle-related diseases

Region

Japan


Condition

Condition

Lifestyle-related diseases

Classification by specialty

Medicine in general Cardiology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Measurement of Syndecan-1 in Medical Checkup

Basic objectives2

Others

Basic objectives -Others

N/A

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Measurement of Syndecan-1 in Medical Checkup

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

100 years-old >

Gender

Male and Female

Key inclusion criteria

Above 20 years old

Key exclusion criteria

Less than 20 years old

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name Hideshi
Middle name
Last name Okada

Organization

Gifu University Hospital

Division name

Advanced Critical Care Center

Zip code

501-1194

Address

1-1, Yanagido, Gifu Japan

TEL

058-230-6448

Email

edm2@gifu-u.ac.jp


Public contact

Name of contact person

1st name Hideshi
Middle name
Last name Okada

Organization

Gifu University Hospital

Division name

Advanced Critical Care Center

Zip code

501-1194

Address

1-1, Yanagido, Gifu Japan

TEL

058-230-6448

Homepage URL


Email

edm2@gifu-u.ac.jp


Sponsor or person

Institute

Gifu University

Institute

Department

Personal name



Funding Source

Organization

Asahi University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Gifu University Graduate School of Medicine

Address

1-1 YANAGIDO

Tel

058-230-6059

Email

rinri@gifu-u.ac.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

2017 Year 11 Month 01 Day


Related information

URL releasing protocol

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6780947/pdf/jcm-08-01320.pdf

Publication of results

Published


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6780947/pdf/jcm-08-01320.pdf

Number of participants that the trial has enrolled

159

Results

The participants enrolled in this study were 1312 patients who underwent comprehensive medical examinations at Asahi University Hospital from Jan 2018 to Jun 2018. At enrollment, blood samples were obtained and study personnea collected demographic and clinical data. According to nonlinear regression, the concentrations of serum syndecan-1 were significantly related to age, AST, BUN, triglyceride concentration and hematocrit. These relationships were independent associations.

Results date posted

2020 Year 03 Month 03 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2019 Year 08 Month 27 Day

Baseline Characteristics

Between January and June 2018, we enrolled 1313 patients. One patient undergoing hemodialysis was excluded from the study, thus, we included 1312 patients, with a median age of 51 years in this study.

Participant flow

Ethical permission was obtained from the medical permission committee of Gifu University Graduate School of Medicine, Gifu, Japan (record no. : 29-214) and Asahi University, Japan (record no. : 30-29), and all patients provided written informed consent.

Adverse events

None

Outcome measures

A priori, we chose to include age, sex, BMI, systolic blood pressure, serum total protein, albumin, total bilirubin, aspartic aminotransferase concentration (AST), alanine transaminase, lactate dehydrogenase, blood urea nitrogen (BUN), creatinine concentration, CRP, fasting blood sugar concentration, hemoglobin a1c, serum triglyceride, high-density lipoprotein-cholesterol, low-density lipoprotein-cholesterol, uric acid concentration, hemoglobin concentration, hematocrit (Ht), white blood cell number, and platelet number in the regression model. To avoid bias in the results by excluding missing data, we used multiple imputations in the regression model.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 09 Month 06 Day

Date of IRB

2017 Year 09 Month 06 Day

Anticipated trial start date

2018 Year 01 Month 01 Day

Last follow-up date

2018 Year 06 Month 30 Day

Date of closure to data entry

2018 Year 12 Month 03 Day

Date trial data considered complete

2018 Year 12 Month 31 Day

Date analysis concluded

2019 Year 02 Month 12 Day


Other

Other related information

N/A


Management information

Registered date

2017 Year 09 Month 13 Day

Last modified on

2020 Year 03 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033312


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name