UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003165 |
|---|---|
| Receipt number | R000003838 |
| Scientific Title | Effects of ezetimibe on glucose metabolism in patients with glucose intolerance |
| Date of disclosure of the study information | 2010/02/10 |
| Last modified on | 2012/08/21 11:22:51 |
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Basic information
Public title
Effects of ezetimibe on glucose metabolism in patients with glucose intolerance
Acronym
Effects of ezetimibe on glucose metabolism in patients with glucose intolerance
Scientific Title
Effects of ezetimibe on glucose metabolism in patients with glucose intolerance
Scientific Title:Acronym
Effects of ezetimibe on glucose metabolism in patients with glucose intolerance
Region
| Japan |
Condition
Condition
Dyslipidemia
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effects of ezetimibe on lipid and glucose metabolism, or adipocytokine in patients with glucose intolerance
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)The change in markers of glucose metabolism
2)The change in serum lipids levels
3)The change in serum hs-CRP level
4)The change in serum adiponectin concentration
Key secondary outcomes
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)Patients diagnosed as glucose intolerance (FPG >110mg/dL, PPG >140mg/dL, HbA1c >5.8% or treated with oral hypoglycemic agents)
2)LDL-C >120mg/dL (In cases of CAD, LDL-C >100mg/dL)
3)Written informed consent is obtained
Key exclusion criteria
1)Poorly controlled diabetes mellitus (HbA1c >8%)
2)Established treatment with colestimide, alufa-GI or insulin
3)Hepatic disorder
4)Renal dysfunction
5)Acute myocardial infarction, unstable angina and stroke within 3 months of enrollment
6)Secondary hyperlipidemia or drug-induced hyperlipidemia
7)Familial hyperlipidemia
8)Ineligible in the opinion of the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Michishita |
Organization
Yokohama Sakae Kyosai Hospital
Division name
Division of Cardiology, Department of Internal Medicine
Zip code
Address
132 Katsura-cho, Sakae-ku, Yokohama
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Nozue |
Organization
Yokohama Sakae Kyosai Hospital
Division name
Division of Cardiology, Department of Internal Medicine
Zip code
Address
TEL
045-891-2171
Homepage URL
Sponsor or person
Institute
Yokohama Sakae Kyosai Hospital
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University
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
| 2010 | Year | 02 | 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
| 2009 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1)The change in markers of glucose metabolism
2)The change in serum lipids levels
3)The change in serum hs-CRP level
4)The change in serum adiponectin concentration
Management information
Registered date
| 2010 | Year | 02 | Month | 10 | Day |
Last modified on
| 2012 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003838
