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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010663
Receipt No. R000012471
Scientific Title The efficacy and safety of low-carbohydrate diet for Japanese patients of type 2 diabetes mellitus
Date of disclosure of the study information 2013/05/10
Last modified on 2017/01/04

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Basic information
Public title The efficacy and safety of low-carbohydrate
diet for Japanese patients of type 2 diabetes mellitus
Acronym The efficacy and safety of low-carbohydrate
diet for Japanese patients of type 2 diabetes mellitus
Scientific Title The efficacy and safety of low-carbohydrate
diet for Japanese patients of type 2 diabetes mellitus
Scientific Title:Acronym The efficacy and safety of low-carbohydrate
diet for Japanese patients of type 2 diabetes mellitus
Region
Japan

Condition
Condition Type 2 Diabetes Mellitus
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Efficacy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Improvement of HbA1c
Key secondary outcomes Body weight
Frequency of hypoglycemia
Lipid metabolism

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is 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-carbohydrate diet
Interventions/Control_2 Japanese diabetic diet
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
75 years-old >=
Gender Male and Female
Key inclusion criteria Patient whose HbA1c has not been improved more than 0.5%, without practicing Japanese diabetic diet properly.
Key exclusion criteria Patient whose HbA1c is less than 7.4%.
Patient whose BMI is less than 22.
Patient who eats carbohydrate less than 130
g/day before registration.
Target sample size 66

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sato, Junko
Organization Juntendo University Graduate School
Division name Department of Metabolism and Endocrinology
Zip code
Address 3-1-3 Hongo Bunkyoku Tokyo
TEL 03-3813-3111
Email jsato@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sato, Junko
Organization Juntendo University Graduate School
Division name Department of Metabolism and Endocrinology
Zip code
Address 3-1-3 Hongo Bunkyoku Tokyo
TEL 03-3813-3111
Homepage URL
Email jsato@juntendo.ac.jp

Sponsor
Institute Juntendo University Graduate School
Institute
Department

Funding Source
Organization Juntendo University Graduate School
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
2013 Year 05 Month 10 Day

Related information
URL releasing protocol
Publication of results Partially 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 04 Month 20 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2016 Year 07 Month 30 Day

Other
Other related information

Management information
Registered date
2013 Year 05 Month 08 Day
Last modified on
2017 Year 01 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012471

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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