UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018629 |
|---|---|
| Receipt number | 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 17:22:27 |
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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
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
akira@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health, Japan, First Department of Internal Medicine, School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021560
