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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018629
Receipt No. R000021560
Scientific Title therapeutic efficacy of ezetimibe and statins for vascular endothelial dysfunction by high-fat diet loadingin patients with type 2 diabetes
Date of disclosure of the study information 2015/08/10
Last modified on 2015/09/10

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Basic information
Public title therapeutic efficacy of ezetimibe and statins for vascular endothelial dysfunction by high-fat diet loadingin patients with type 2 diabetes
Acronym Effects of ezetimibe on vascular endothelial dysfunction
Scientific Title therapeutic efficacy of ezetimibe and statins for vascular endothelial dysfunction by high-fat diet loadingin patients with type 2 diabetes
Scientific Title:Acronym Effects of ezetimibe on vascular endothelial dysfunction
Region
Japan

Condition
Condition Type 2 diabetes
Hyperlipidemia
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of the present study was to determine the effects of ezetimibe and statins for high fat diet loading induced endothelial dysfunction tested by peripheral arterial tonometry in type 2 diabetes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary endpoint was the difference between RHI changes following treatment with each of the two drugs.
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 ezetimibe
subjects were allocated randomly by the envelope method to either of two treatment groups: ezetimibe 10 mg/day or rosuvastatin 2.5 mg/day. After 1-week oral administration of the allocated drug, the high-fat diet-loading test was conducted
Interventions/Control_2 rosuvastatin
subjects were allocated randomly by the envelope method to either of two treatment groups: ezetimibe 10 mg/day or rosuvastatin 2.5 mg/day. After 1-week oral administration of the allocated drug, the high-fat diet-loading test was conducted
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
80 years-old >
Gender Male and Female
Key inclusion criteria The research participants were type 2 diabetes, aged between 20 and 79 years, who were not being treated for dyslipidemia, at the University of Occupational and Environmental Health, Department of Endocrinology, Metabolism and Diabetes and affiliated hospitals.
Key exclusion criteria We excluded patients treated with insulin, and those with abnormalities in the electro-cardiogram.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiya Tanaka
Organization University of Occupational and Environmental Health
Division name First Department of Internal Medicine, School of Medicine
Zip code
Address 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu
TEL 093-603-1611
Email tanaka@med.uoeh-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Kurozumi
Organization University of Occupational and Environmental Health
Division name First Department of Internal Medicine, School of Medicine
Zip code
Address 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu
TEL 093-603-1611
Homepage URL
Email akira@med.uoeh-u.ac.jp

Sponsor
Institute University of Occupational and Environmental Health, Japan, First Department of Internal Medicine, School of Medicine
Institute
Department

Funding Source
Organization Environmental Health, Japan, First Department of Internal Medicine, School of Medicine
Organization
Division
Category of Funding Organization Other
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
2015 Year 08 Month 10 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
2012 Year 05 Month 14 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 08 Month 10 Day
Last modified on
2015 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021560

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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