UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Retrospective observational study examining the effects of endothelial function on the prognosis
Title of the study (Brief title)	Retrospective observational study examining the effects of endothelial function on the prognosis
Region	Japan

Condition
Condition	diabetes mellitus
Classification by specialty	Medicine in general Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To prove the efficacy of the endothelial function as a predictor of cardiovascular prognosis by retrospective observation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Relationship between endothelial function and composite cardiovascular events that occurred after the endothelial function measurement.
Key secondary outcomes	1. All death. 2. Composite cardiovascular events and peripheral artery disease. 3. Composite cardiovascular events, peripheral artery disease and heart failure. 4. The induction of hemodialysis. 5. The rate of decrease in eGFR.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The series of 1400 consecutive patients performed endothelial function tests from January 2005 to December 2015 in at the department of medicine in Shiga University Hospital. They were performed under the following conditions. 1. Able to keep resting position of the whole body and upper limbs. 2. No arrhythmia 3. All test was performed by only one clinical laboratory technician throughout the study.
Key exclusion criteria	This study is a retrospective observational study, carried out by the opt-out method of our hospital website. We have excluded the case, which we determined inaccuracy due to multiple arrhythmia and poor physical condition on the test day.
Target sample size	1400

Research contact person
Name of lead principal investigator	Katsutaro Morino
Organization	Shiga University of Medical Science
Division name	Department of Medicine, Division of Diabetes, Nephrology and Neurology
Address	Seta Tsukinowa, Otsu, Shiga, Japan 520-2192
TEL	077-548-2222
Email	morino@belle.shiga-med.ac.jp

Public contact
Name of contact person	Katsutaro Morino
Organization	Shiga University of Medical Science
Division name	Department of Diabetes, Nephrology and Neurology
Address	Seta Tsukinowa, Otsu, Shiga, Japan 520-2192
TEL	077-548-2222
Homepage URL	http://www.shiga-med.ac.jp/hospital/doc/department/department/secretion/index.html
Email	sumsdmg@gmail.com

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Shiga University of Medical Science
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 06 Month 24 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 05 Month 09 Day
Anticipated trial start date	2016 Year 06 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	The main observation items: 1. The endotherial function 2. Composite cardiovascular events. 3. All death. 4. Composite cardiovascular events and peripheral artery disease. 5. Composite cardiovascular events, peripheral artery disease and heart failure. 6. The induction of hemodialysis. 7. The rate of decrease in eGFR.

Management information
Registered date	2016 Year 06 Month 24 Day
Last modified on	2016 Year 06 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026286