UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025308 |
|---|---|
| Receipt number | R000024202 |
| Scientific Title | Effects of isomaltodextrin (IMD) on glucose, insulin, glucagon and incretins: Comparison with maltodextrin in healthy volunteers |
| Date of disclosure of the study information | 2016/12/17 |
| Last modified on | 2017/05/30 13:50:23 |
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Basic information
Public title
Effects of isomaltodextrin (IMD) on glucose, insulin, glucagon and incretins: Comparison with maltodextrin in healthy volunteers
Acronym
IMD-01
Scientific Title
Effects of isomaltodextrin (IMD) on glucose, insulin, glucagon and incretins: Comparison with maltodextrin in healthy volunteers
Scientific Title:Acronym
IMD-01
Region
| Japan |
Condition
Condition
Type 2 diabetes, obesity
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This cross-over trial is designed to compare effects of isomaltodextrin with those of maltodextrin on glucose, insulin, C-peptide, glucagon and incretins (GLP-1 and GIP).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma levels of GIP and GLP-1 before and after ingestion of IMD or MD; and their area under the curves
Key secondary outcomes
Levels of glucose, insulin, C-peptide, and glucagon before and after ingestion of IMD or MD; and their area under the curves
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Isomaltodextrin (IMD) 50g
Interventions/Control_2
maltodextrin (MD) 50g
Interventions/Control_3
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
| 75 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Healthy volunteers without diabetes
2. Gender: Male and female
3. BMI(kg/m2) at screening: 18 or more; and 30 or less
4. Age (years) at screening: 20 or more; and 75 or less
Key exclusion criteria
1. Individuals receiving anti-diabetic drugs
2. Individuals with renal impairment
3. Individuals with hepatic impairment
4. Individuals with history of cerebrovascular disorders and/or ischemic heart diseases
5. Individuals with heart failure (NYHA I-IV)
6. Individuals with history of GI surgery
7. Individuals with excess alcohol consumption
8. Individuals with low Hb values: male, < 13.0g/dL and female 12.5 g/dL
9. Individuals who cannot follow orders from chief investigator or sub investigator
10. Individuals enrolled in other clinical trials
11. Pregnant individuals or those suspected of pregnancy
12. Individuals who are judged as inappropriate to be enrolled in this trials by chief investigator or sub investigators
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Susumu Seino |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Molecular and Metabolic Medicine
Zip code
Address
1-5-6 Minatojimaminamimachi, Chuo-ku, Kobe 650-0047, Japan
TEL
078-304-6061
seino@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Yabe |
Organization
Kansai Electric Power Hospital
Division name
Center for Diabetes, Endocrinology and Metabolism
Zip code
Address
2-1-7 Fukushima, Osaka 553-0003, Japan
TEL
06-6458-5821
Homepage URL
ydaisuke-kyoto@umin.ac.jp
Sponsor or person
Institute
Division of Molecular and Metabolic Medicine, Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hayashibara Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kansai Electric Power Hospital
Name of secondary funder(s)
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 17 | 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
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 17 | Day |
Last modified on
| 2017 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024202
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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