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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015443
Receipt No. R000017835
Scientific Title Efficacy of brown rice for blood glucose control in patients with type 2 diabetes
Date of disclosure of the study information 2014/10/20
Last modified on 2014/10/14

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Basic information
Public title Efficacy of brown rice for blood glucose control in patients with type 2 diabetes
Acronym The effect of brown rice on postprandial hyperglycemia
Scientific Title Efficacy of brown rice for blood glucose control in patients with type 2 diabetes
Scientific Title:Acronym The effect of brown rice on postprandial hyperglycemia
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to compare the increase of postprandial blood glucose among white rice (WR), brown rice (BR) and brown glutinous rice (BGR) in patients who have suffered in type 2 diabetes (T2D).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes A blood glucose circadian variation by measuring continuous glucose monitoring (CGM)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 white rice
Interventions/Control_2 brown rice
Interventions/Control_3 glutinous brown rice
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1. Patient who obtained document agreement by free will of himself on understanding after enough explanation when participating about examination is received
2. Hospitalized patients
3. From 140mg/dL on down in fasting and from 200 mg/dL on down after the meal for 2 hours
Key exclusion criteria 1. T1DM patients
2. Patient who is taking medicine that influences postprandial glucose level
3. Woman who has possibility of pregnancy or getting pregnant
4. Breast-feeding woman
5. It is a woman who is menstruating for the conducting of the examination period.
6. Patients who judged unsuitable by physician to this study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasushi Tanaka
Organization St. Marianna University School of Medicine
Division name Metabolism and Endocrinology
Zip code
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa
TEL 044-977-8111
Email y2tanaka@marianna-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuko Terashima
Organization St. Marianna University School of Medicine
Division name Metabolism and Endocrinology
Zip code
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa
TEL 044-977-8111
Homepage URL
Email k-sienbu.mail@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization YAZUYA Food and Health Research Centre
Organization
Division
Category of Funding Organization Non profit foundation
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
2014 Year 10 Month 20 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
2012 Year 11 Month 29 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 29 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
2014 Year 10 Month 16 Day
Last modified on
2014 Year 10 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017835

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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