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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043398
Receipt No. 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 2021/02/20

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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
Email 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
Email maenishi@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical university
Division of Clinical Nutrition and Metabolism
Institute
Department

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
Email 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 Enrolling by invitation
Date of protocol fixation
2019 Year 05 Month 07 Day
Date of IRB
2019 Year 05 Month 14 Day
Anticipated trial start date
2024 Year 03 Month 31 Day
Last follow-up date
2024 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
2021 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049548

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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