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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025767
Receipt No. R000029642
Scientific Title The study for association between circulating angiopoetin like protein 2 (ANGPTL2) and various markers related to diabetes in patients with type 2 diabetes
Date of disclosure of the study information 2017/01/22
Last modified on 2017/06/30

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Basic information
Public title The study for association between circulating angiopoetin like protein 2 (ANGPTL2) and various markers related to diabetes in patients with type 2 diabetes
Acronym Association between circulating ANGPTL2 and various markers related to DM in T2DM patients
Scientific Title The study for association between circulating angiopoetin like protein 2 (ANGPTL2) and various markers related to diabetes in patients with type 2 diabetes
Scientific Title:Acronym Association between circulating ANGPTL2 and various markers related to DM in T2DM patients
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 investigate the association between ANGPTL2 and various markers related to type 2 diabetes or atherosclerosis or between ANGPTL2 and degrees of progression of diabetic complications by cross-sectional analysis
Basic objectives2 Others
Basic objectives -Others The association between ANGPTL2 and other bloods markers excluding Narrative objectives1
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Association between ANGPTL2 and various markers related to type 2 diabetes or atherosclerosis or between ANGPTL2 and degrees of progression of diabetic complications (cross-sectional)
Key secondary outcomes None

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

Not applicable
Gender Male and Female
Key inclusion criteria 1) patients (male or femal) aged 20 or over at enrollment
2) patients diagnosed as type 2 diabetes (based on criteria in Japan Diabetes Society 2010)
3)Patients who are hospitalized for glycemic control for type 2 diabetes
4)patients giving consent in writing for participation for this study
Key exclusion criteria 1)Patients with type 1 diabetes, pancreatic diabetes or secondary diabetes (Cushing syndrome, acromegaly etc.) diabetic coma or diabetic pre-coma, or type 1 diabetes
2)Patients under pregnancy, possible pregnancy, or lactation
3)Furthermore, patients judged as inadequacy for participation in this study by medical doctor
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kohzo Takebayashi
Organization Dokkyo Medical University Koshigaya Hospital
Division name Internal Medicine (Diabetes, Endocrinology, Hematology)
Zip code
Address 2-1-50 Minamikoshigaya, Koshigaya, Saitama, Japan
TEL 048-965-1111
Email takebaya@dokkyomed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kohzo Takebayashi
Organization Dokkyo Medical University Koshigaya Hospital
Division name Internal Medicine (Diabetes, Endocrinology, Hematology)
Zip code
Address 2-1-50 Minamikoshigaya, Koshigaya, Saitama, Japan
TEL 048-965-1111
Homepage URL
Email takebaya@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University Koshigaya Hospital
Institute
Department

Funding Source
Organization None (Self funding)
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

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 22 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
2017 Year 01 Month 18 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Cross-sectional study

Management information
Registered date
2017 Year 01 Month 20 Day
Last modified on
2017 Year 06 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029642

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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