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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011265
Receipt No. 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

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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
Email 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
Email taktak319@yahoo.co.jp

Sponsor
Institute Hyogo Brain and Heart Center
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013200

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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