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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029135
Receipt No. 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

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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
Institute Gifu University
Institute
Department

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
URL(English) https://upload.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


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