UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020453
Receipt number 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 17:10:45

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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 or person

Institute

Yokohama City University hospital

Institute

Department

Personal name



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

Value
https://center6.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