UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003186 |
|---|---|
| Receipt number | 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 14:18:20 |
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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
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
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
No
Name of secondary funder(s)
No
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003861
