UMIN-CTR Clinical Trial

Basic information
Public title	Assessment of efficacy and safety of ezetimibe in patients with dyslipidemia complicated insulin resistance.
Acronym	Assessment of efficacy and safety of ezetimibe in patients with dyslipidemia complicated insulin resistance.
Scientific Title	Assessment of efficacy and safety of ezetimibe in patients with dyslipidemia complicated insulin resistance.
Scientific Title:Acronym	Assessment of efficacy and safety of ezetimibe in patients with dyslipidemia complicated insulin resistance.
Region	Japan

Condition
Condition	Dyslipidemia complicated insulin resistance
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The effect of the improvement on the insulin resistance and the internal organs obesity and the fatty liver of Ezetimib for the patients with dyslipidemia complicated insulin resistance is clarified.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1)Flow Mediated Dilation test 2)Volume of visceral fat and fatty liver) 3)Improvement ratio of Cholesterol Absorption and Synthesis Markers 4)Improvement ratio of Oxidized low density lipoprotein and Atherogenic lipoprotein level 3)
Key secondary outcomes	1)Improvement ratio of glucose metabolism makers 2)Improvement of inflammatory makers and Oxidation makers

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Take Ezetimib:10mg/day for 12 months.
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)LDL-C>=120mg/dL 2)Patients not change drug therapy for anti-dyslipidemic and/or anti-diabetic agent within 12weeks of the study entry. 3)HOMA-IR>=2.5 or BMI>=25
Key exclusion criteria	1)HbA1c>=8% 2)Patients with anamnesis for anaphylaxis of ezetimibe tablets 3)Complicated with Severe renal and/or hepatic disease 4)Having anamnesis of myocardial infarction, angina and/or stroke 5)Patients with secondary hyperlipidemia or drug-associated hyperlipidemia 6)Patients who are pregnant or lactating women and women suspected of being pregnant 7)Patients of Familial hyperlipidemia 8)Other patients deemed not appropriate for study entry by the investigator.
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Odawara Middle name Last name Masato
Organization	Tokyo Medical University
Division name	The Department of Diabetes, Endocrinology and Metabolism
Zip code	1600023
Address	6-7-1 Nishi Shinjuku, Shinjuku-ku, Tokyo 160-0023
TEL	03-3342-6111
Email	odawara@tokyo-med.ac.jp

Public contact
Name of contact person	1st name Miwa Middle name Last name Takashi
Organization	Tokyo Medical University
Division name	The Department of Diabetes, Endocrinology and Metabolism
Zip code	1600023
Address	6-7-1 Nishi Shinjuku, Shinjuku-ku, Tokyo 160-0023
TEL	03-3342-6111
Homepage URL
Email	miwa-t@tokyo-med.ac.jp

Sponsor
Institute	The Department of Diabetes, Endocrinology and Metabolism, Tokyo Medical University Hospital
Institute
Department

Funding Source
Organization	The Department of Diabetes, Endocrinology and Metabolism, Tokyo Medical University Hospital
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	Tokyo Medical University
Address	6-1-1 Shinjuku, Shinjuku-ku, Tokyo
Tel	0333426111
Email	kenkyu-s@tokyo-med.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	東京医科大学病院

Other administrative information
Date of disclosure of the study information	2011 Year 06 Month 20 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	47
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	Because paper is being submitted.
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	2009 Year 12 Month 28 Day
Date of IRB	2013 Year 10 Month 30 Day
Anticipated trial start date	2010 Year 05 Month 01 Day
Last follow-up date	2012 Year 03 Month 01 Day
Date of closure to data entry	2012 Year 04 Month 01 Day
Date trial data considered complete	2012 Year 04 Month 01 Day
Date analysis concluded	2012 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date	2011 Year 06 Month 14 Day
Last modified on	2019 Year 12 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006824