UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000025998
Receipt No. 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

* 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
Email 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
Email t2nakayama@marianna-u.ac.jp

Sponsor
Institute St Marianna University school of medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029887

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.