UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015925 |
|---|---|
| Receipt number | R000018046 |
| Scientific Title | The clinical study of correlation between cholesterol-lowering therapy and the progression of atherosclerosis in type 2 diabetes mellitus |
| Date of disclosure of the study information | 2014/12/12 |
| Last modified on | 2016/09/14 11:41:13 |
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Basic information
Public title
The clinical study of correlation between cholesterol-lowering therapy and the progression of atherosclerosis in type 2 diabetes mellitus
Acronym
The clinical study of correlation between cholesterol-lowering therapy and the progression of atherosclerosis in type 2 diabetes mellitus
Scientific Title
The clinical study of correlation between cholesterol-lowering therapy and the progression of atherosclerosis in type 2 diabetes mellitus
Scientific Title:Acronym
The clinical study of correlation between cholesterol-lowering therapy and the progression of atherosclerosis in type 2 diabetes mellitus
Region
| Japan |
Condition
Condition
Atherosclerotic disease in type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Normal therapy group are intervened based on guidline, Japan Atherosclerosis Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012, with the goal of lowering LDL-C to less than 120 mg/dl. Intensive therapy group, are intervened with the goal of lowering LDL-C to less than 80 mg/dl, with which it is reported that coronary plaque can regression by meta-analysis of clinical trial data. To establish the most effective lipid lowering therapy, this study will investigate the difference of the atherosclerotic progression between intensive therapy group and standard therapy group.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.the progression of intima-media thickness
2.the progression of pulse wave velocity
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine | Other |
Interventions/Control_1
< intensive therapy group >
Based on guidline, Japan Atherosclerosis Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012, with the goal of lowering LDL-C to less than 80 mg/dl.
Interventions/Control_2
< standard therapy group >
Based on guidline, JAS Guidelines 2012, with the goal of lowering LDL-C to less than 120 mg/dl.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Type 2 Diabetes Mellitus patients whose LDL-C more than 120 mg/dL at the time of the clinical study start
Key exclusion criteria
1.The patients with cerebrovascular disease that developed recently, within 12 weeks.
2.The patients whose fasting triglyceride level>400 mg/dl
3.The patients who have histry of coronary heart disease
4.The patients with liver disfunction
5.The patients with renal disfunction, serum creatinine level is mere than 2 times of the facilities standard.
6.The patients with uncontroled respiratory failure, heart failure and arrhythmia etc.
7.The patients with Familial hypercholesterolemia.
8.The patients with alcoholicsm or medicinal intoxication.
9.The patients who are pregnant, lactating and may be pregnant.
10.The patients who doctors judge as unfitness.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Matsumura |
Organization
Kumamoto University Hospital
Division name
Metabolism and Endocrinology
Zip code
Address
1-1-1 Honjo, Chuo, Kumamoto, 860-8556, Japan
TEL
096-373-5169
takeshim@gpo.kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Matsumura |
Organization
Kumamoto University Hospital
Division name
Metabolism and Endocrinology
Zip code
Address
1-1-1 Honjo, Chuo, Kumamoto, 860-8556, Japan
TEL
096-373-5169
Homepage URL
takeshim@gpo.kumamoto-u.ac.jp
Sponsor or person
Institute
Human Ethics Review Committee of Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
This work was supported by a Grant-in-Aid for Scientific Research from the Japan Society for the Promotion of Scienc, Japan.
Organization
Division
Category of Funding Organization
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
| 2014 | Year | 12 | Month | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 12 | Day |
Last modified on
| 2016 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018046
