UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025314 |
|---|---|
| Receipt number | 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 21:31:35 |
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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
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
t2nakayama@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029117
