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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008157
Receipt No. R000009595
Scientific Title Effects of Bezafibrate on Lipid and glucose metabolism in dyslipidemic patients with impaired glucose tolerance - Comparative analysis of the characteristics of dyslipidemia improving drugs for postprandial metabolic disorder.-
Date of disclosure of the study information 2012/06/13
Last modified on 2013/12/14

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Basic information
Public title Effects of Bezafibrate on Lipid and glucose metabolism in dyslipidemic patients with impaired glucose tolerance - Comparative analysis of the characteristics of dyslipidemia improving drugs for postprandial metabolic disorder.-
Acronym BRILLIANT study
Scientific Title Effects of Bezafibrate on Lipid and glucose metabolism in dyslipidemic patients with impaired glucose tolerance - Comparative analysis of the characteristics of dyslipidemia improving drugs for postprandial metabolic disorder.-
Scientific Title:Acronym BRILLIANT study
Region
Japan

Condition
Condition Patients with metabolic syndrome
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effects of bezafibrate and atrovastatin on lipid and glucose metabolism in patients with metabolic syndrome
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes 1) Levels of triglycerides, HDL-cholesterol, total cholesterol and LDL-cholesterol
2) Diameter of lipoproteins measured by HPLC
3)HbA1c (NGSP) and 75g OGTT (glucose and insulin levels at 0, 30, 60 and 120 min after glucose load)
4)Safety (Adverse effects including hypoglycemia, body weigh gain)
Key secondary outcomes 1)MDA-LDL levels and MDA-LDL/LDL cholesterol
2)Insulin sensitivity (HOMA-IR, QUICKI)
3)Plasma adiponectin levels
4)Plasma high sensitive C reactive protein levels
5)Body weight, body mass index (BMI) and blood pressure
6)Renal function and liver function tests

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Participants in the bezafibrate treatment group will be received 400mg/day of bezafibrate during 3 months. If a patient's consent is obtained, the treatmentwill be continued for more 3 months.
Interventions/Control_2 Participants in the atrovastatin treatment group will be received 10mg/day of atrovastatin during 3months. If a patient's consent is obtained, the treatment will be continued vfor more 3 months.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients who have metabolic syndrome according to IDF definition without history of coronary heart disease.
2) Patients who have triglyceride levels of 150mg/dL or higher and have LDL cholesterol levels of 120mg/dL or higher after an overnight fasting.
3) Patients who give informed consent.
Key exclusion criteria 1) Patients who have contraindication of bezafibrate or atrovastatin treatment.
2) Patients who have taken any lipid-lowering drug within one month.
3) Patient who have taken any antidaibetic agents.
4) Alcoholic patients.
5) Patients judged to be unsuitable participants by physician-in-charge
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazunori Shimada
Organization Juntendo University Hospital
Division name Department of Cardiovascular Medicine
Zip code
Address Hongo 3-1-3, Bunkyo-ku, Tokyo, Japan
TEL 03-3813-3111
Email shimakaz@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazunori Shimada
Organization Juntendo University Hospital
Division name Department of Cardiovascular Medicine
Zip code
Address Hongo 3-1-3, Bunkyo-ku, Tokyo, Japan
TEL 03-3813-3111
Homepage URL
Email shimakaz@juntendo.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine,
Juntendo University School of Medicine
Institute
Department

Funding Source
Organization None
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
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 順天堂大学附属順天堂医院(東京都)

Other administrative information
Date of disclosure of the study information
2012 Year 06 Month 13 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
2012 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 01 Day
Last follow-up date
2014 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 06 Month 13 Day
Last modified on
2013 Year 12 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009595

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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