UMIN-CTR Clinical Trial

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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