UMIN-CTR Clinical Trial

Basic information
Public title	Meal loading Effects on endothelial function, Adipocytokine and Lipid metabolism investigation
Acronym	MEAL investigation
Scientific Title	Meal loading Effects on endothelial function, Adipocytokine and Lipid metabolism investigation
Scientific Title:Acronym	MEAL investigation
Region	Japan

Condition
Condition	diabetes, hypertension, hyperlipidemia, ischemic heart disease
Classification by specialty	Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To identify the effect of postprandial hyperglycemia and hyperlipidemia on vascular dysfunction, we performe meal tolarance test. To identify the simple screening method for glucose intolerance using urine samples collected before and after the test meal consumption.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Postprandial change of blood glucose, insulin, TG, ApoB48, incretin, blood pressure, pule and augmentation indx. onset of glucose intolerance, diabetes and cardiovascular disease.
Key secondary outcomes	Pre- and Postprandial change of urinary myoinositol.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Food
Interventions/Control_1	meal tolerance test(500 Kcal, protein 10 g, fat 29 g, carbohydrate 50 g)
Interventions/Control_2
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	satisfied with the criteria of age and not included excluded criteria.
Key exclusion criteria	severe diabetes severe hyperlipidemia diabetic patient with insulin therapy past history of allergy to test meal (wheat or milk) pregnancy liver dysfunction cancer, collagen disease, infection renal dysfunction (serum Cr>2mg/dl) The patient whom Doctor decide insufficient to the study
Target sample size	200

Research contact person
Last name of lead principal investigator	1st name Yasunori Middle name Last name Takata
Organization	Ehimeuniversity, graduate school of medicine
Division name	Department of Diabetes and molecular genetics
Zip code	791-0295
Address	Sitsukawa, Toon city, Ehime, Japan
TEL	089-960-5647
Email	ytakata@m.ehime-u.ac.jp

Public contact
1st name of contact person	1st name Yasunori Middle name Last name Takata
Organization	Ehimeuniversity, graduate school of medicine
Division name	Department of Diabetes and molecular genetics
Zip code	791-0295
Address	Sitsukawa, Toon city, Ehime, Japan
TEL	089-960-5647
Homepage URL
Email	ytakata@m.ehime-u.ac.jp

Sponsor
Institute	Department of Diabetes and molecular genetics, Ehimeuniversity, graduate school of medicine
Institute
Department

Funding Source
Organization	Japan Diabetes Fundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board, Ehime University Hospital
Address	Sitsukawa, Toon, zip 791-0295, Ehime
Tel	089-960-5914
Email	souyaku-post@m.ehime-u.ac.jp

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	2009 Year 04 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
Date of protocol fixation	2006 Year 12 Month 22 Day
Date of IRB
Anticipated trial start date	2007 Year 01 Month 01 Day
Last follow-up date	2009 Year 12 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	2009 Year 04 Month 13 Day
Last modified on	2019 Year 03 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000002263