UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011265 |
|---|---|
| Receipt number | R000013200 |
| Scientific Title | Evaluation of the impact of eicosapentaenoic acid on postprandial hyperglycemia, hyperliopemia and endothelial dysfunction in mild diabetic and impaired glucose tolerance patients with coronary artery disease. |
| Date of disclosure of the study information | 2013/08/13 |
| Last modified on | 2016/08/16 06:52:07 |
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Basic information
Public title
Evaluation of the impact of eicosapentaenoic acid on postprandial hyperglycemia, hyperliopemia and endothelial dysfunction in mild diabetic and impaired glucose tolerance patients with coronary artery disease.
Acronym
Evaluation of the impact of eicosapentaenoic acid on postprandial hyperglycemia, hyperliopemia and endothelial dysfunction in mild diabetic and impaired glucose tolerance patients with coronary artery disease.
Scientific Title
Evaluation of the impact of eicosapentaenoic acid on postprandial hyperglycemia, hyperliopemia and endothelial dysfunction in mild diabetic and impaired glucose tolerance patients with coronary artery disease.
Scientific Title:Acronym
Evaluation of the impact of eicosapentaenoic acid on postprandial hyperglycemia, hyperliopemia and endothelial dysfunction in mild diabetic and impaired glucose tolerance patients with coronary artery disease.
Region
| Japan |
Condition
Condition
untreated mild diabetic patients (HbA1c<7.0%) and impaired glucose tolearence
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the impact of eicosapentaenoic acid on postprandial hyperglycemia and hyperlipemia and endothelial dysfunction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Flow-mediated dilatation as an endothleial function after 6 months treatment.
Key secondary outcomes
postprandial hyperglycemia and hyperlipemia after cookie meal test after 6months treatment.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
eicosapentanoeic acid
Interventions/Control_2
life style improvement
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Impaired glucose tolearance patients diagnosed by 75g carbohydrate tolerance test or untreated mild diabetic patients (HbA1c<7.0%)
Key exclusion criteria
chronic renal failure (Cr>2.0mg/dL)
steroid user
chronic inflammatory disease (infection, collagen disease, malignant disease)
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Sawada |
Organization
Hyogo Brain and Heart Center
Division name
Division of Cardiovascular medicine
Zip code
Address
520, Saisyou-Kou, Himeji
TEL
079-293-3131
taktak319@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Sawada |
Organization
Hyogo Brain and Heart Center
Division name
Division of Cardiovascular medicine
Zip code
Address
Saisho-kou 520, Himeji, Hyogo
TEL
079-293-3131
Homepage URL
taktak319@yahoo.co.jp
Sponsor or person
Institute
Hyogo Brain and Heart Center
Institute
Department
Personal name
Funding Source
Organization
Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
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
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
| 2013 | Year | 08 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2013 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 24 | Day |
Last modified on
| 2016 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013200
