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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003186
Receipt No. R000003861
Scientific Title Effects of indigestible dextrin 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

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Basic information
Public title Effects of indigestible dextrin on postprandial glucose level ,lipid value and incretin secretion in healty subjects and type 2 diabetic patients
Acronym indigestible dextrin and incretin
Scientific Title Effects of indigestible dextrin on postprandial glucose level ,lipid value and incretin secretion in healty subjects and type 2 diabetic patients
Scientific Title:Acronym indigestible dextrin 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 indigestible dextrin
Interventions/Control_2 Administration of indigestible dextrin once
Interventions/Control_3 Administration of indigestible dextrin 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
Institute Graduate School of Medicine, Yokohama City University
Institute
Department

Funding Source
Organization No
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor No
Name of secondary funder(s) No

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 Enrolling by invitation
Date of protocol fixation
2009 Year 10 Month 20 Day
Date of IRB
Anticipated trial start date
2009 Year 12 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003861

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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