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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020453
Receipt No. R000023450
Scientific Title Circulating SerpinB1 levels in Japanese patients with type 2 diabetes.
Date of disclosure of the study information 2016/01/08
Last modified on 2016/01/14

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Basic information
Public title Circulating SerpinB1 levels in Japanese patients with type 2 diabetes.
Acronym Circulating SerpinB1 levels in type 2 diabetes.
Scientific Title Circulating SerpinB1 levels in Japanese patients with type 2 diabetes.
Scientific Title:Acronym Circulating SerpinB1 levels in type 2 diabetes.
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the role of serum SerpinB1 in the physiological significance in patients with type 2 diabetes
Basic objectives2 Others
Basic objectives -Others To determine the physiological significance
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Serum SerpinB1 level
Key secondary outcomes The association of the serum SerpinB1 with the various metabolic parameters is analyzed in enrolled subjects.

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
70 years-old >
Gender Male and Female
Key inclusion criteria <Type 2 diabetes group>
Hospitalized Patients with type 2 diabetes who fulfilled the following criteria.
1) Age is over 20 and below 70.
2) Patients diagnosed with type 2 diabetes.
3) Having provided voluntary written consent for participation in this study.
<Control group>
Hospitalized Patients with nontype 2 diabetes who fulfilled the following criteria.

1) Age is over 20 and below 70.
2) Patients who are not diagnosed with type 2 diabetes.
3) Having provided voluntary written consent for participation in this study.
Key exclusion criteria Patients corresponding to any of the following are inapplicable
< Type 2 diabetes group>
1)Patients with severe complications( liver disease, mental disorder, cancer)
2)Patients with severe ketosis or diabetic coma.
3)Patients with severe infections, perioperative status, or severe trauma
4) Patients whose baseline eGFR wewre <29 ml/min/1.73m^2
5)Pregnancy or lactation in women
6) Patients who are judged by an investigator to be inappropriate for this study for any other reason.
<Control group>
1)Patients with severe complications( liver disease, mental disorder, cancer)
2)Patients with severe infections, perioperative status, or severe trauma
3)Pregnancy or lactation in women
4) Patients who are judged by an investigator to be inappropriate for this study for any other reason.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuo Terauchi
Organization Yokohama City University Graduate School of Medicine
Division name Department of Endocrinology and Metabolism
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama
TEL 045-787-2800
Email terauchi@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuki Tajima
Organization Yokohama City University Graduate School of Medicine
Division name Department of Endocrinology and Metabolism
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama
TEL 045-787-2800
Homepage URL
Email kztajima@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 横浜市立大学附属病院 (神奈川県)

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 08 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 Open public recruiting
Date of protocol fixation
2015 Year 11 Month 14 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 08 Day
Last follow-up date
2017 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Cross-sectional study
Recruitment of Subject:
Hospitalized Patients with type 2 diabetes or non-type2 diabetes
in Yokohama City University hospital who fulfilled the inclusion/exclusion criteria from January 2016 through 30 September 2017.
To determine the role of serum SerpinB1 in the physiological significance in patients with type 2 diabetes

Management information
Registered date
2016 Year 01 Month 06 Day
Last modified on
2016 Year 01 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023450

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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