UMIN-CTR Clinical Trial

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