UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief 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.
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	Takahiro Sawada
Organization	Hyogo Brain and Heart Center
Division name	Division of Cardiovascular medicine
Address	520, Saisyou-Kou, Himeji
TEL	079-293-3131
Email	taktak319@yahoo.co.jp

Public contact
Name of contact person	Takahiro Sawada
Organization	Hyogo Brain and Heart Center
Division name	Division of Cardiovascular medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000013200