UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005783 |
|---|---|
| Receipt number | R000006842 |
| Scientific Title | Survey research on the effects of statin alone or a combination of statin and EPA on endothelial function in patients with type 2 diabetes complicated with dyslipidemia |
| Date of disclosure of the study information | 2011/06/17 |
| Last modified on | 2012/07/03 19:38:48 |
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Basic information
Public title
Survey research on the effects of statin alone or a combination of statin and EPA on endothelial function in patients with type 2 diabetes complicated with dyslipidemia
Acronym
Survey research on the effects of statin alone or a combination of statin and EPA on endothelial function in patients with type 2 diabetes complicated with dyslipidemia
Scientific Title
Survey research on the effects of statin alone or a combination of statin and EPA on endothelial function in patients with type 2 diabetes complicated with dyslipidemia
Scientific Title:Acronym
Survey research on the effects of statin alone or a combination of statin and EPA on endothelial function in patients with type 2 diabetes complicated with dyslipidemia
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the current study is to examine the relationship between type 2 diabetes mellitus complicated with dyslipidemia and dysfunctions of the endothelial cells; and to discover the effects of EPA on the endothelial function. It is also intended to utilize the findings for the prevention and treatment of complications of type 2 diabetes mellitus.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Assessing endothelial function of patients with type 2 diabetes, using strain-gauge plethysmography.
Key secondary outcomes
Pulse wave velocity(PWV) and intima-media thickness(IMT) of carotid artery echogram before and after EPA administration.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Continuing statin alone: a statin preparation (type unspecified, at a normal dosage)
Interventions/Control_2
A combination with EPA: a statin preparation + Epadel of 1,800 mg a day.
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
| 30 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients with type 2 diabetes mellitus, complicated with dyslipidemia and who have given written informed consent to participate in the current study.
Key exclusion criteria
Those patients who meet any of the following conditions were excluded from the current study:
1) Currently suffer from cerebral hemorrhage or have had it in the past
2) Have embolism or hemorrhagic infarction
3) Are currently suffering from a hemorrhage (conditions such as hemophilia, capillary fragility, hemorrhage from the digestive system, urinary tract hemorrhage, hemoptysis, and vitreous hemorrhage)
4) Have severe congestive heart failure
5) Have a history of hypersensitivity to statin or components of EPA
6) Have a peptic ulcer
7) Have a severe hematological anomaly
8) Have a severe complication (such as a malignant tumor, liver cirrhosis, renal failure and heart failure)
9) Those who failed to give informed consent
10) Other patients whom the chief investigator or attending physician finds unsuitable
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Odawara |
Organization
Tokyo Medical University
Division name
The Department of Diabetes, Endocrinology and Metabolism
Zip code
Address
6-7-1 Nishi Shinjuku, Shinjuku-ku, Tokyo 160-0023
TEL
03-3342-6111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Miwa |
Organization
Tokyo Medical University
Division name
The Department of Diabetes, Endocrinology and Metabolism
Zip code
Address
6-7-1 Nishi Shinjuku, Shinjuku-ku, Tokyo
TEL
Homepage URL
miwa-t@tokyo-med.ac.jp
Sponsor or person
Institute
The Department of Diabetes, Endocrinology and Metabolism, Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
The Department of Diabetes, Endocrinology and Metabolism, Tokyo Medical 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
東京医科大学病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/endocrj/59/4/59_EJ11-0394/_article
Number of participants that the trial has enrolled
Results
In patients with type 2 diabetes and receiving statin therapy whose LDL-C level was less than 100 mg/dL, the addition of highly purified EPA for 6 months significantly improved vascular function.
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
| 2006 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 15 | Day |
Last modified on
| 2012 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006842
