UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015443 |
|---|---|
| Receipt number | 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 18:00:01 |
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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
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
k-sienbu.mail@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017835
