UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001879 |
|---|---|
| Receipt number | 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 12:24:17 |
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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
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
ytakata@m.ehime-u.ac.jp
Sponsor or person
Institute
Department of Diabetes and molecular genetics, Ehimeuniversity, graduate school of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002263
