UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of monounsaturated fatty acid and sitagliptin on insulin secretion and endothelial function (EMSIE study)
Title of the study (Brief title)	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	Michio Shimabukuro
Organization	The University of Tokushima Graduate School of Health Biosciences
Division name	Department of Cardio-Diabetes Medicine
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	Michio Shimabukuro
Organization	The University of Tokushima Graduate School of Health Biosciences
Division name	Department of Cardio-Diabetes Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 03 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000015202