UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003184
Receipt number R000003860
Scientific Title Effects of wheat albumin on postprandial glucose level ,lipid value and incretin secretion in healty subjects and type 2 diabetic patients
Date of disclosure of the study information 2010/02/15
Last modified on 2011/08/15 14:19:23

* 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

Effects of wheat albumin on postprandial glucose level ,lipid value and incretin secretion in healty subjects and type 2 diabetic patients

Acronym

wheat albumin and incretin

Scientific Title

Effects of wheat albumin on postprandial glucose level ,lipid value and incretin secretion in healty subjects and type 2 diabetic patients

Scientific Title:Acronym

wheat albumin and incretin

Region

Japan


Condition

Condition

Diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Development of efficient diabetic treatment and lifestyle-related diseases prevention

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

postprandial incretin secretion

Key secondary outcomes

1.postprandial glucose level
2.postprandial lipid level
3.postprandial insulin secretion


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


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

No administration of wheat albumin

Interventions/Control_2

Administration of wheat albumin once

Interventions/Control_3

Administration of wheat albumin for seven days

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

18 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

1.Diabetic patients and healthy subjects.
2.Subjects who provided written informed concent.

Key exclusion criteria

1.Patients who are receiving insulin therapy.
2.Patients who have a severe hepatic dysfunction.
3.Patients who have a severe renal dysfunction.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuo Terauchi

Organization

Graduate School of Medicine, Yokohama City University

Division name

Department of Endocrinology and Metabolism

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Kiyomi Masuda

Organization

Graduate School of Medicine, Yokohama City University

Division name

Department of Endocrinology and Metabolism

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama

TEL


Homepage URL


Email



Sponsor or person

Institute

Graduate School of Medicine, Yokohama City University

Institute

Department

Personal name



Funding Source

Organization

No

Organization

Division

Category of Funding Organization

Self funding

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

横浜市立大学附属病院(神奈川県)


Other administrative information

Date of disclosure of the study information

2010 Year 02 Month 15 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

Open public recruiting

Date of protocol fixation

2010 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2010 Year 02 Month 01 Day

Last follow-up date

2013 Year 03 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 02 Month 15 Day

Last modified on

2011 Year 08 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003860


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name