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

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 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


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

Value
https://center6.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