UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008157 |
|---|---|
| Receipt number | 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 | 2023/03/03 09:13:03 |
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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
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
shimakaz@juntendo.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine,
Juntendo University School of Medicine
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2012 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 07 | Month | 01 | Day |
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
| 2023 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009595
