UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025998 |
|---|---|
| Receipt number | R000029887 |
| Scientific Title | Investigation the effect of imprpving on postprandial blood glucose with type 2 diabetic patients by the combination of bran ingestion and alpha glucosidase inhibitor |
| Date of disclosure of the study information | 2017/02/04 |
| Last modified on | 2018/07/16 21:07:39 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Investigation the effect of imprpving on postprandial blood glucose with type 2 diabetic patients by the combination of bran ingestion and alpha glucosidase inhibitor
Acronym
the effect of improving on postprandial blood glucose by the combination of bran ingestion and alpha glucosidase inhibitor
Scientific Title
Investigation the effect of imprpving on postprandial blood glucose with type 2 diabetic patients by the combination of bran ingestion and alpha glucosidase inhibitor
Scientific Title:Acronym
the effect of improving on postprandial blood glucose by the combination of bran ingestion and alpha glucosidase inhibitor
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism | Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirm the ingestion of brown rice bran alone before meals, ingestion of bran and pre-meal ingestion of alpha glucosidase inhibitor in combination with each other, and changes in postprandial blood glucose of each when not taking anything in advance
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1 Mean blood glucose of 24 hours
2 MAGE (average value of differences in blood glucose level when blood glucose fluctuation exceeding average + 1SD)
3 total area of blood glucose fluctuation in 24 hours
4 Percentage of time zone of hyperglycemia (> 140 mg / dL)
5 Percentage of time zone of hypoglycemia (<70 mg / dL)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of unpolished rice bran before meals
Interventions/Control_2
Combined administration of brown rice bran and pre-meal alpha glucosidase inhibitor
Interventions/Control_3
No meals before administration
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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients whose age is over 20 years old but less than 75 years old when acquiring consent
2. After receiving sufficient explanation for the participation of this study, patients who obtained document consent by the patient's free will with sufficient understanding
3. Patient in hospital
4. Patients whose blood glucose level is not more than 140 mg / dL on an empty stomach and below 200 mg / dL for 2 hours after a meal
Key exclusion criteria
1. Type 1 diabetic patients
2. Patients who have used alpha GI and GLP 1 analog preparations so far
3. Patients using alpha glucosidase inhibitor and GLP-1 analog preparations
4. Women who may be pregnant or may become pregnant
5. Women who are breastfeeding
6. Women in menstruation during the study period
7. Patients determined by the attending physician to be unsuitable for this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Tanaka |
Organization
St Marianna University School of Medicine
Division name
Metabolism and Endocrinology
Zip code
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa
TEL
044-977-8111
y2tanaka@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taiga Nakayama |
Organization
St. Marianna University School of Medicine
Division name
Metabolism and Endocrinology
Zip code
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa
TEL
044-977-8111
Homepage URL
t2nakayama@marianna-u.ac.jp
Sponsor or person
Institute
St Marianna University school of medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 02 | Month | 04 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 04 | Day |
Last modified on
| 2018 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029887
