UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002469 |
|---|---|
| Receipt number | R000003023 |
| Scientific Title | Cholesterol lowerling effect of ezetimibe on hypercholesterolemic patients with type2 diabetes. |
| Date of disclosure of the study information | 2009/09/08 |
| Last modified on | 2011/11/01 09:26:15 |
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Basic information
Public title
Cholesterol lowerling effect of ezetimibe on hypercholesterolemic patients with type2 diabetes.
Acronym
Zetia study
Scientific Title
Cholesterol lowerling effect of ezetimibe on hypercholesterolemic patients with type2 diabetes.
Scientific Title:Acronym
Zetia study
Region
| Japan |
Condition
Condition
type2 diabetes patients with hypercholesterolemia
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the cholesterol lowering effect of diet thjerapy by hospitalyzation and treatment of ezetimibe on type2 diabetes patients with hypercholesterolemia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Reduction rate of LDL-C for 1 week after hospitalization.
2. Reduction rate of LDL-C after treatment of ezetimibe.
Key secondary outcomes
1. Reduction rate of TC, HDL-C, TG, RLP-C and sdLDL-C for 1 week after hospitalization.
2. Reduction rate of TC, HDL-C, TG, RLP-C and sdLDL-C after treatment of ezetimibe.
3. Correlation between markers of cholesterol synthesis or absorption and reduction rate of TC, LDL-C, HDL-C, TG, RLP-C and sdLDL-C for 1 week after hospitalization.
4. Correlation between markers of cholesterol synthesis or absorption and reduction rate of TC, LDL-C, HDL-C, TG, RLP-C and sdLDL-C after ezetimibe treatment.
5. Correlation between reduction rate of LDL-C for 1 week after hospitalization and reduction rate of LDL-C after ezetimibe treatment.
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
After hospitalization of type2 diabetes patients, they were treated with diet therapy of hypercholesterolemia (limit of cholesterol intake by less than 300 mg per day). After 1 week, they were treated with ezetimibe (10 mg/day) for 6 weeks.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Typr2 diabetes patients with hypercholesterolemia (LDL-c>120mg/dl), which are able to hospitalize.
Key exclusion criteria
1. patients with cerebrovasucular disease (onset within 12 weeks).
2. patients over 500 mg/dl of TG.
3. patients with cardiovascular disease.
4. patients with liver disfunction.
5. patients with renal disfunction.
6. patients who are estimated not to continue this study by serious diseases.
7. patients with familial hypercholesterolemia.
8. secondary hypercholesterolemia.
9. patients with alcholism or medicinal poisoning.
10. medicinal allergy.
11. patients with pregnancy.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Matsumura |
Organization
Graduate School of Medical Science, Kumamoto University.
Division name
Department of Metabolic Medicine
Zip code
Address
1-1-1 Honjo, Kumamoto, 860-8556, Japan.
TEL
096-373-5169
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Matsumura |
Organization
Graduate School of Medical Science, Kumamoto University.
Division name
Department of Metabolic Medicine
Zip code
Address
TEL
Homepage URL
takeshim@gpo.kumamoto-u.ac.jp
Sponsor or person
Institute
Department of Metabolic Medicine, Graduate School of Medical Science, Kumamoto University.
Institute
Department
Personal name
Funding Source
Organization
Department of Metabolic Medicine, Graduate School of Medical Science, Kumamoto University.
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
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
熊本大学医学部附属病院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 09 | Month | 08 | 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
| 2009 | Year | 02 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 08 | Day |
Last modified on
| 2011 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003023
