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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025314
Receipt No. R000029117
Scientific Title A study concerning to the effect of glycometabolic measurments by eating glutinous brown rice for over a medium term in Japanese patients with diabetes mellitus
Date of disclosure of the study information 2016/12/18
Last modified on 2018/07/16

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Basic information
Public title A study concerning to the effect of glycometabolic measurments by eating glutinous brown rice for over a medium term in Japanese patients with diabetes mellitus
Acronym The effect of glycometabolic improvements by eating glutinous brown rice continuously for over a medium term
Scientific Title A study concerning to the effect of glycometabolic measurments by eating glutinous brown rice for over a medium term in Japanese patients with diabetes mellitus
Scientific Title:Acronym The effect of glycometabolic improvements by eating glutinous brown rice continuously for over a medium term
Region
Japan

Condition
Condition non-insulin independent diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to discuss the effect of glycometabolic measurements by eating glutinous broen rice for 8 weeks in Japanese people with non-insulin independent diabetes mellitus
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the change of HbAic after eating glutinousbrown rice for 8 weeks
Key secondary outcomes the change of glycoalbumin, 1,5-AG, plasma glucose, and serum C peptide after eating glutinousbrown rice for 8 weeks

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Cluster
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 glutinous brown rice<GBR>
(eating for 8 weeks, twice a day, the amount of GBR per one meal which was based on the amount of stample food per one meal in everyday life)
Interventions/Control_2 white rice<WR>
(eating for 8 weeks, twice a day, the amount of WR per one meal which was based on the amount of stample food per one meal in everyday life)
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
74 years-old >=
Gender Male and Female
Key inclusion criteria 1) 20 years of age or older
2) stable glycemic control (6.0%< HbA1c<8.9%)
3) receiving multiple daily injection (MDI) with or without oral hypoglycemic agents
Key exclusion criteria 1) 75 years of age or older
2) an insulin-dependent status
3) severe renal dysfunction(estimated glomerular filtration rate <30 mL/min/1.73 m2)
4) women who were pregnant, possibly pregnant, or planned to become pregnant and breast-feeding women
5) patients who were considered to be ineligible for the study by their attending doctor for other reasons
Target sample size 20

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 Taiga Nakayama
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 t2nakayama@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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
2016 Year 12 Month 18 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/28481338
Number of participants that the trial has enrolled
Results
Diabetes subjects improved HbA1c and glycoalbumin by ingesting glutinous brown rice for 8weeks.
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
2014 Year 12 Month 22 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 08 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
2016 Year 12 Month 18 Day
Last modified on
2018 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029117

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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