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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003809
Receipt No. R000004600
Scientific Title Effect of low-fat, high-fiber diet intervention on glycemic and lipid control and endothelial function in type2 diabetes
Date of disclosure of the study information 2010/07/01
Last modified on 2013/01/06

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Basic information
Public title Effect of low-fat, high-fiber diet intervention on glycemic and lipid control and endothelial function in type2 diabetes
Acronym Effect of low-fat, high-fiber diet intervention on glycemic and lipid control and endothelial function in type2 diabetes
Scientific Title Effect of low-fat, high-fiber diet intervention on glycemic and lipid control and endothelial function in type2 diabetes
Scientific Title:Acronym Effect of low-fat, high-fiber diet intervention on glycemic and lipid control and endothelial function 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 low-fat, high- fiber diet intervention on glycemic and lipid control and endothelial function in type2 diabetes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of glucose, lipid profile, and endothelial function after diet intervention.
Key secondary outcomes Change of oxidative stress and periodontitis marker after 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 Low-fat, high-fiber diet intervention period of 2month
Interventions/Control_2 control period of 2month
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

Not applicable
Gender Male and Female
Key inclusion criteria HbA1c level of 6.0 % or more and below 10.0 %
Key exclusion criteria (1)Patient with severe vascular disease
(2)Patient with severe hepatic or renal disease
(3)Patients with cancer disease
(4)Patients with infectious disease
(5)taking alpha-GI
(6)Previous use of warfarin within 1 month
(7)insulin treatment
(8)Patient who change drug treatment within the 2-month period
(9)Patient with rapid weight loss
(10)Patient who enrolled in another study within 1 month
(11)vegetable allergy, vegetarian
(12)Pregnancy and breast-feeding patient
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiko Nishio
Organization Department of Medicine, Shiga University of Medical Science
Division name Department of Medicine
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 Keiko Kondo
Organization Department of Medicine, Shiga University of Medical Science
Division name Department of Medicine
Zip code
Address Tsukinowa, Seta, Otsu, Shiga 520-2192
TEL 077-548-2223
Homepage URL
Email kon@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Institute
Department

Funding Source
Organization Shiga University of Medical Science
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
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
2010 Year 07 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
2008 Year 11 Month 25 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 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
2010 Year 06 Month 23 Day
Last modified on
2013 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004600

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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