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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034317
Receipt No. R000039121
Scientific Title Analysis of ANGPTL in diabetes with dyslipidemia
Date of disclosure of the study information 2018/09/28
Last modified on 2019/08/15

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Basic information
Public title Analysis of ANGPTL in diabetes with dyslipidemia
Acronym Analysis of ANGPTL
Scientific Title Analysis of ANGPTL in diabetes with dyslipidemia
Scientific Title:Acronym Analysis of ANGPTL
Region
Japan

Condition
Condition diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine the relationship between lifestyle diseases such as diabetes, obesity, insulin resistance, arteriosclerotic disease, dyslipidemia, and angiopoietin-like protein (ANGPTL).
Basic objectives2 Others
Basic objectives -Others We examine how ANGPTLs change by improving lipid and glycemic control.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between diabetes-related numerical values (insulin resistance, HbA1c) and ANGPTLs
Key secondary outcomes 1) Arteriosclerosis: Correlation with carotid artery echo, macroangiopathy, presence of minimum vascular disease, etc. with ANGPTL
2) Obesity: Correlation between BMI, visceral fat area and ANGPTL
3) Lipid-related: Correlation between Apo protein, fatty acid fraction, LPL, etc. and ANGPTL
4) Change in ANGPTL due to improvement in blood glucose / lipid metabolism

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)patient taking oral lipid-related drugs or having dyslipidemia
2) Patients who are on diet therapy, exercise therapy only or oral hypoglycemic drug or insulin treatment.
3) Patients who can obtain written consent for participation in this study
Key exclusion criteria Patients with severe ketosis, diabetic coma or precoma, severe infections, patients with severe trauma.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Tadashi
Middle name
Last name Yamakawa
Organization Yokohama City University Medical Center
Division name Department of Endocrinology and Diabetes
Zip code 232-0024
Address 4-57 Urafune-cho, Mimami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Email naibunpi@urahp.yokohama-cu.ac.jp

Public contact
Name of contact person
1st name Marina
Middle name
Last name Harada
Organization Yokohama City University Medical Center
Division name Department of Endocrinology and Diabetes
Zip code 232-0024
Address 4-57 Urafune-cho, Mimami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Homepage URL
Email onyogora@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Medical Center
Institute
Department

Funding Source
Organization DAIICHI SANKYO COMPANY
Sanofi
Ono Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Medical Research Ethics Committee for Humans
Address 3-9 Fukuura Kanazawa-ku Yokohama Japan
Tel 0453707627
Email rinri@yokohama-cu.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 横浜市立大学附属市民総合医療センター

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 28 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 Completed
Date of protocol fixation
2018 Year 08 Month 23 Day
Date of IRB
2018 Year 09 Month 26 Day
Anticipated trial start date
2018 Year 09 Month 26 Day
Last follow-up date
2019 Year 03 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information ANGPTL2,3,4,8

Management information
Registered date
2018 Year 09 Month 28 Day
Last modified on
2019 Year 08 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039121

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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