UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013023 |
|---|---|
| Receipt number | R000015202 |
| Scientific Title | Effects of monounsaturated fatty acid and sitagliptin on insulin secretion and endothelial function (EMSIE study) |
| Date of disclosure of the study information | 2014/02/14 |
| Last modified on | 2018/08/13 09:22:43 |
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Basic information
Public title
Effects of monounsaturated fatty acid and sitagliptin on insulin secretion and endothelial function (EMSIE study)
Acronym
EMSIE study
Scientific Title
Effects of monounsaturated fatty acid and sitagliptin on insulin secretion and endothelial function (EMSIE study)
Scientific Title:Acronym
EMSIE study
Region
| Japan |
Condition
Condition
Healthy volunteer and patients with type 2 diabetes mellitus
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study effects of monounsaturated fatty acid and sitagliptin on insulin secretory profiles and endothelial function in healthy volunteer and in patients with type 2 diabetes mellitus
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure, glucose, insulin, lipids, GIP, GLP-1, adipocytokines and %change of flow- and nitroglycerine-mediated dilatation before and after meal tolerance test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Medicine | Food |
Interventions/Control_1
carbohydrate 75 g (300kcal)
Interventions/Control_2
carbohydrate 75 g (300kcal) + butter (240kcal)
Interventions/Control_3
carbohydrate 75 g (300kcal) + oliveoil 27 g (240kcal)
Interventions/Control_4
carbohydrate 75 g (300kcal) + sitagliptin 50mg
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy volunteer and type 2 diabetes mellitus, who agree to the study protocol
Key exclusion criteria
1. Medication affecting study results
2. Poor diabetes control
3. Severe infection, operation and trauma before 3 months
4. Severe liver or kidney dysfunction
5. Other inappropriate causes
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michio Shimabukuro |
Organization
The University of Tokushima Graduate School of Health Biosciences
Division name
Department of Cardio-Diabetes Medicine
Zip code
Address
3-18-15 Kuramoto, Tokushima 770-8503, Japan
TEL
080-633-7859
mshimabukuro-ur@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michio Shimabukuro |
Organization
The University of Tokushima Graduate School of Health Biosciences
Division name
Department of Cardio-Diabetes Medicine
Zip code
Address
3-18-15 Kuramoto, Tokushima 770-8503, Japan
TEL
080-633-7859
Homepage URL
mshimabukuro-ur@umin.ac.jp
Sponsor or person
Institute
Department of Cardio-Diabetes Medicine, The University of Tokushima Graduate School of Health Biosciences
Institute
Department
Personal name
Funding Source
Organization
Department of Cardio-Diabetes Medicine, The University of Tokushima Graduate School of Health Biosciences
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
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
| 2014 | Year | 02 | Month | 14 | 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
| 2013 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | 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
| 2014 | Year | 01 | Month | 30 | Day |
Last modified on
| 2018 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015202
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
