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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002070
Receipt No. R000002498
Scientific Title Correlation between cholesterol absorption and atherogenic risk factors in hypercholesterolemic patients with type2 diabetes.
Date of disclosure of the study information 2009/12/31
Last modified on 2010/06/14

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Basic information
Public title Correlation between cholesterol absorption and atherogenic risk factors in hypercholesterolemic patients with type2 diabetes.
Acronym The efficacy of inhibiting cholesterol absorption in hypercholesterolemic patients wiht type2 diabetes
Scientific Title Correlation between cholesterol absorption and atherogenic risk factors in hypercholesterolemic patients with type2 diabetes.
Scientific Title:Acronym The efficacy of inhibiting cholesterol absorption in hypercholesterolemic patients wiht type2 diabetes
Region
Japan

Condition
Condition Hypercholesterolemic patients with type2 diabetes
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We considered that cholesterol absorption correlates with atherogenic risk factors in hypercholesterolemic patients with type2 diabetes. Furthermore, we demonstrate the efficacy of treatment with ezetimibe in these subject.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The efficacy of ezetimibe on LDL-cholesterol reduction.
Key secondary outcomes

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 Ezetimibe
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 LDL-C>120mg/dL
LDL-C<180mg/dL
patients with type2 diabetes treating over 4weeks
Key exclusion criteria HbA1c>10.0% or increasing or decreasing over 2% on HbA1c during past 3months
patients with serious hepatic dysfunction
Serum creatinine>2.0mg/dL
Familyal hypercholesterolemia
Pregnancy or Lactation
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiko, Iwamoto
Organization Tokyo Women's Medical University
Division name Diabetes center
Zip code
Address 8-1, Kawada-cho, Shinzyuku-ku, Tokyo, 162-8666 Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tokyo Women's Medical University
Division name Diabetes canter
Zip code
Address 8-1, Kawada-cho, Shinzyuku-ku, Tokyo, 162-8666 Japan
TEL 03-3353-8111
Homepage URL
Email

Sponsor
Institute Diabetes canter, Tokyo women's medical university
Institute
Department

Funding Source
Organization None
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
2009 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
1) Increased cholesterol absorption markers in patients with statin treatment or patients with microvascular complicatoin.
2) Serum lipid prfiles significantlly improved after ezetimibe treatment.
3) Cholesterol absorption markers decreased with ezetimibe treatment.  
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
2008 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 10 Month 01 Day
Last follow-up date
2009 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
2010 Year 10 Month 01 Day
Date analysis concluded
2010 Year 11 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 06 Month 12 Day
Last modified on
2010 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002498

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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