UMIN-CTR Clinical Trial

Basic information
Public title	Study on the interaction between barley beta-glucan and pharmaceutical products
Acronym	Study on the interaction between barley beta-glucan and pharmaceutical products
Scientific Title	Study on the interaction between barley beta-glucan and pharmaceutical products
Scientific Title:Acronym	Study on the interaction between barley beta-glucan and pharmaceutical products
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	Evaluate whether barley improves glycemic control of diabetic patients taking alpha-GI or metfolmin and reduces the risk of arteriosclerosis via incretins or inflammatory cytokines. The subjects shall be those who have (a) not received drug therapy, (b) taken alpha-GI (acarbose) and (c) taken metformin.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Blood glucose (0, 30, 60, 90, 120 min)
Key secondary outcomes	CGM Data Insulin (0, 30, 60, 90, 120 min) Inflammation related factor (0, 120 min) Incretin (0, 30, 60, 120 min) Feeding hormone (0, 30, 60, 120 min) Safety data: Weight, BMI Blood pressure measurement General biochemical test Blood cell test Questionnaire: Advance questionnaire Questionnaire(Test day) Diet survey form

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Diet and exercise therapy group The first day(D0), doctor's hearing, meal tolerance test and installation of CGM are implemented. During a ingestion period, ingest 2 packs of white rice a day (D1 to D5), then ingest 2 packs of barley mixed rice a day (D6 to D12 or D13). Meal tolerance tests are implemented again on the final day (D13 or D14). Test meals should be eaten as a staple foods of breakfast and supper. All subjects should record about their intake of meals and drugs. Meal tolerance test: 1) The day before tests The day before the glucose tolerance test, refrain from excessive exercise, drinking alcohol and sitting up late. After 9 p.m., prohibit eating and drinking except water. 2) Test day Measuring body weight, blood pressure and pulse in the hospital at the test day. Collecting fasting blood. Answer questionnaires of test day such as meal time of the previous day, sleeping time, exercise time of the previous day and so on. 3) Intake of test foods After collecting fasting blood, intake test meals. Test meals should be rice and energy-adjusted curry on the first day and barley mixed rice and energy-adjusted curry on the last day. 4) Blood collection Blood is collected at 30, 60, 90, and 120 minutes after intake test meals.
Interventions/Control_2	Diet/exercise therapy + alpha-GI (acarbose) group Except subjects, same as Interventions/Control 1.
Interventions/Control_3	Diet/exercise therapy + metformin group Except subjects, same as Interventions/Control 1.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Type 2 diabetic patients who satisfy one of the following conditions. A) Those who are treated with diet / exercise only. B) In addition to diet / exercise therapy, those taking alpha-GI (acarbose). C) In addition to diet / exercise therapy, those taking metformin. Those taking acarbose or metformin should not change the dosage more than 60 days before D0. (2) Persons whose HbA1c are 6.5 to 8.5% (when obtaining consent). (3) Persons who are over 20 years old. (4) Persons who obtained consent.
Key exclusion criteria	(1) Serious ketosis, diabetic coma or precoma, patients with dialysis and type 1 diabetic patients. (2) Patients with diseases or trauma such as serious infection, before and after surgery, cancer, etc. (3) Those who are taking hypoglycemic drugs except the drugs listed in the selection criteria. (4) Persons who merged gastrointestinal disorders affecting digestion / absorption. (5) Persons who have a medical history of gastrointestinal resection. (6) Persons who merged serious liver and kidney problems (as judged by a doctor). (7) Persons who developed myocardial infarction / stroke within 180 days before D0. (8) Persons who take systemic steroids (excluding local). (9) Smokers. (10) Persons who are drinking excessively (For example, 180 mL or more of sake per day, three or more big bottles of beer per day). (11) Persons who have a history of hypersensitivity (food allergy etc.) to the test meals (barley, rice, wheat, milk ingredients, apples, beef, pork, soybeans and sesame). (12) Persons who usually consume barley. (13) Pregnant women or ladies who may be pregnant. (14) Others who are judged inappropriate by the representative doctor.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Takeshi Middle name Last name Osonoi
Organization	Nakakinen Clinic Medical corporation kensei-kai
Division name	Director
Zip code	311-0113
Address	745-5,Nakadai,Naka-city,Ibaraki-ken,311-0113,Japan
TEL	029-353-2800
Email	t-osonoi@kensei-kai.com

Public contact
Name of contact person	1st name Kensuke Middle name Last name Ofuchi
Organization	Nakakinen Clinic Medical corporation kensei-kai
Division name	Department of clinical research
Zip code	311-0113
Address	745-5,Nakadai,Naka-city,Ibaraki-ken,311-0113,Japan
TEL	029-353-2800
Homepage URL
Email	k-ofuchi@kensei-kai.com

Sponsor
Institute	Nakakinen Clinic Medical corporation kensei-kai
Institute
Department

Funding Source
Organization	Hakubaku CO.,LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Faculty of Life and Environmental Sciences,University of Yamanashi
Name of secondary funder(s)	None

IRB Contact (For public release)
Organization	Ethics committee of Nakakinen clinic
Address	745-5,Nakadai,Naka-city,Ibaraki-ken,311-0113,Japan
Tel	029-353-2800
Email	k-ofuchi@kensei-kai.com

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	医療法人　健清会　那珂記念クリニック（茨城県）

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 10 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	2017 Year 07 Month 25 Day
Date of IRB
Anticipated trial start date	2017 Year 08 Month 11 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete	2018 Year 03 Month 31 Day
Date analysis concluded	2018 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date	2017 Year 08 Month 10 Day
Last modified on	2021 Year 01 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032595