UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028623 |
|---|---|
| Receipt number | R000032595 |
| Scientific Title | Study on the interaction between barley beta-glucan and pharmaceutical products |
| Date of disclosure of the study information | 2017/08/10 |
| Last modified on | 2021/01/06 10:41:54 |
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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
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
k-ofuchi@kensei-kai.com
Sponsor or person
Institute
Nakakinen Clinic Medical corporation kensei-kai
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032595
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