UMIN-CTR Clinical Trial

Basic information
Public title	Clinical study on the changes in the vascular endothelial function by the intervention for hypertriglyceridemia in patients with type 2 diabetes treated with statin.
Acronym	Interventional study on type2 diabetes with hypertriglyceridemia.
Scientific Title	Clinical study on the changes in the vascular endothelial function by the intervention for hypertriglyceridemia in patients with type 2 diabetes treated with statin.
Scientific Title:Acronym	Interventional study on type2 diabetes with hypertriglyceridemia.
Region	Japan

Condition
Condition	Type 2 diabetes patients with hypertriglyceridemia
Classification by specialty	Endocrinology and Metabolism Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In type 2 diabetic patients, it is well known that treatment of hyper-LDL cholesterolemia is very important. However, Sufficient consideration has not been paid for the treatment of hypertriglyceridemia. Subjects are the patients with type2 diabetes and hypertriglyceridemia showing normal LDL cholesterole level after treatment with statin. All patients are randomly assigned to open-label treatment with either statin or ezetimib/fenofibrate. The purpose of this study is to investigate the effect of the treatment for hypertriglyceridemia on the changes in the lipid profile and vascular endothelial function.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We compare the lipoprotein profile and FMD(flow mediated dilation) between the two groups(Statin group and Ezetimibe/fenofibrate combination group). we compare also changes in postprandial hypertriglyceridemia.
Key secondary outcomes	Before and after Cookies meal test, relation between lipid parameters(total cholesterol, triglycerides, HDL, LDL, LPL, apoprotein) and FMD.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The continued treatment with statin, and cookies meal test is performed to evaluate postprandial hypertriglyceridemia.
Interventions/Control_2	It's changed to treatment with ezetimib/fenofibrate from treatment with statin, and cookies meal test performed to evaluate postprandial hypertriglyceridemia.
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	LDL <=120 mg/dl TG >=120 mg/dl HbA1c <=8.0%
Key exclusion criteria	HbA1c > 8.0%. Patients with severe liver dysfunction. Patients with history of hypersensitivity to study drugs. Serum creatinine >= 2.5 mg/dl. Patients with secondary properties and drug-induced lipid abnormalities. Patients with familial hypercholesterolemia. Pregnancy example. Patients with history of coronary artery disease.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Yoshihiko Middle name Last name NIshio
Organization	Kagoshima University Graduate School of Medical and Dental Sciences
Division name	Department of Diabetes and Endocrinology
Zip code	890-8520
Address	8-35-1 Sakuragaoka, Kagoshima, Japan
TEL	099-275-6478
Email	info@kadai-tounai.com

Public contact
Name of contact person	1st name Atsushi Middle name Last name Shinnakasu
Organization	Kagoshima University Graduate School of Medical and Dental Sciences
Division name	Department of Diabetes and Endocrinology
Zip code	890-8520
Address	8-35-1 Sakuragaoka, Kagoshima, Japan
TEL	099-275-6478
Homepage URL
Email	atushi312@yahoo.co.jp

Sponsor
Institute	Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department

Funding Source
Organization	Kagoshima University Graduate School of Medical and Dental Sciences
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Bayer
Name of secondary funder(s)	Immuno-Biological Laboratory

IRB Contact (For public release)
Organization	Kagoshima University Hospital Clinical Research Center
Address	8-35-1 Sakuragaoka, Kagoshima, Japan
Tel	099-275-5553
Email	info@kadai-tounai.com

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	2015 Year 03 Month 03 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	2014 Year 12 Month 01 Day
Date of IRB	2015 Year 01 Month 14 Day
Anticipated trial start date	2015 Year 01 Month 14 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 03 Month 02 Day
Last modified on	2019 Year 09 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019353