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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013023
Receipt No. 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

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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
Email 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
Email mshimabukuro-ur@umin.ac.jp

Sponsor
Institute Department of Cardio-Diabetes Medicine, The University of Tokushima Graduate School of Health Biosciences
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015202

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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