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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001879
Receipt No. R000002263
Scientific Title Meal loading Effects on endothelial function, Adipocytokine and Lipid metabolism investigation
Date of disclosure of the study information 2009/04/15
Last modified on 2019/03/25

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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
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
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/ctr_e/ctr_view.cgi?recptno=R000002263

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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