UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043398 |
|---|---|
| Receipt number | R000049548 |
| Scientific Title | Comparative study of inhibitory effects on postprandial blood glucose levels of patients with type 2 diabetes by wax bran layer removal brown rice |
| Date of disclosure of the study information | 2021/02/20 |
| Last modified on | 2023/03/28 17:58:20 |
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Basic information
Public title
Comparative study of inhibitory effects on postprandial blood glucose levels of patients with type 2 diabetes by wax bran layer removal brown rice
Acronym
Inhibitory effects on blood glucose levels by wax bran layer removal rice
Scientific Title
Comparative study of inhibitory effects on postprandial blood glucose levels of patients with type 2 diabetes by wax bran layer removal brown rice
Scientific Title:Acronym
Inhibitory effects on blood glucose levels by wax bran layer removal rice
Region
| Japan |
Condition
Condition
Type 2 Diabetes Mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirmation of inhibitory effects on postprandial glucose levels of patients with type 2 diabetes by wax bran layer removal rice
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area under the curve during 0-120min after rice ingestion analyzed by FGM
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
wax bran layer removal rice
Interventions/Control_2
polished rice
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
Inpatients with type 2 diabetes
HbA1c above or equal to 7.5% and less than 10.5%
Key exclusion criteria
severe ketosis or diabetic coma within six weeks
severe hypoglycemia within six weeks
severe renal dysfunction or under dialysis therapy
proliferative retinopathy
severe gastrointestinal dysfunction within two weeks or operation of GI tract
pregnant or breastfeeding
severe infection or severe trauma
glucocorticoid therapy
severe liver dysfunction
malignancy
hypersensitive to rice
difficulty to eat test meal
judged as inappropriate by attending physician
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Nishi |
Organization
Wakayama Medical University
Division name
Division of Clinical Nutrition and Metabolism
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama-City, Wakayama prefecture
TEL
073-441-0625
mnishi@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Sae |
| Middle name | |
| Last name | Maenishi |
Organization
Wakayama Medical University
Division name
Division of Clinical Nutrition and Metabolism
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama-City, Wakayama prefecture
TEL
073-441-0513
Homepage URL
maenishi@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical university
Division of Clinical Nutrition and Metabolism
Institute
Department
Personal name
Funding Source
Organization
Toyo Rice Co.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Toyo Rice Corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Wakayama Medical University
Address
811-1 Kimiidera, Wakayama-City, Wakayama prefecture
Tel
073-447-2300
wa-rinri@wakyama-med.ac.jp
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
| 2021 | Year | 02 | 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
| 2019 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 20 | Day |
Last modified on
| 2023 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049548
