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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002277
Receipt No. R000002786
Scientific Title Effect of fish-based diet intervention on endothelial function and serum adiponectin concentration in type2 diabetes
Date of disclosure of the study information 2009/08/01
Last modified on 2012/02/01

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Basic information
Public title Effect of fish-based diet intervention on endothelial function and serum adiponectin concentration in type2 diabetes
Acronym Effect of fish-based diet intervention on endothelial function and serum adiponectin concentration in type2 diabetes
Scientific Title Effect of fish-based diet intervention on endothelial function and serum adiponectin concentration in type2 diabetes
Scientific Title:Acronym Effect of fish-based diet intervention on endothelial function and serum adiponectin concentration in type2 diabetes
Region
Japan

Condition
Condition type 2 diabetic patient
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of fish-based diet on endothelial function and serum adiponectin concentration in type2 diabetes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change of endothelial function and serum adiponectin concentration after the fish-diet intervention.
Key secondary outcomes Change of glucose, lipid profile, and oxidative stress marker after the fish-diet intervention.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 fish-diet intervention period of 4weeks (n-3PUFA>3.0g/day)
Interventions/Control_2 control period of 4weeks
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
55 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Type2 diabetic patient (frequency of fish intake<7 times/week, HbA1c<8.0%)
Key exclusion criteria 1)taking pioglitazone
2)taking EPA
3)insulin treatment
4)fish allergy
5)smoking
6)excessive alcohol ingestion
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsutaro Morino
Organization Department of Medicine, Shiga University of Medical Science
Division name Division of Endocrinology and Metabolism
Zip code
Address Tsukinowa, Seta, Otsu, Shiga 520-2192
TEL 077-548-2223
Email

Public contact
Name of contact person
1st name
Middle name
Last name Katsutaro Morino
Organization Department of Medicine, Shiga University of Medical Science
Division name Division of Endocrinology and Metabolism
Zip code
Address Tsukinowa, Seta, Otsu, Shiga 520-2192
TEL 077-548-2223
Homepage URL
Email morino@belle.shiga-med.ac.jp

Sponsor
Institute Department of Medicine, Division of Endocrinology and Metabolism, Shiga University of Medical Science
Institute
Department

Funding Source
Organization Department of Medicine, Division of Endocrinology and Metabolism, Shiga University of Medical Science
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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
2009 Year 08 Month 01 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 Completed
Date of protocol fixation
2009 Year 07 Month 21 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 07 Month 31 Day
Last modified on
2012 Year 02 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002786

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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