UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003297 |
|---|---|
| Receipt number | R000003991 |
| Scientific Title | Pilot study of plasma acylcarnitinine profiles after meal load in Japanese patients with type 2 diabetes patients |
| Date of disclosure of the study information | 2010/04/01 |
| Last modified on | 2010/03/07 22:40:25 |
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Basic information
Public title
Pilot study of plasma acylcarnitinine profiles after meal load in Japanese patients with type 2 diabetes patients
Acronym
Pilot study of plasma acylcarnitinine profiles after meal load in Japanese patients with type 2 diabetes patients
Scientific Title
Pilot study of plasma acylcarnitinine profiles after meal load in Japanese patients with type 2 diabetes patients
Scientific Title:Acronym
Pilot study of plasma acylcarnitinine profiles after meal load in Japanese patients with type 2 diabetes patients
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Final aim is to find a novel plasma marker related to fatty acid metabolism to predict insulin resistance in subjects with glucose intolerance. As pilot study, plasma acylcarnitinine profiles after meal load are measured in non-diabetcic and diabetic subjects to obtain fundamental information for future full study.
Basic objectives2
Others
Basic objectives -Others
Plasma acylcarnitinine profiles after meal load are measured and are compared in non-diabetcic and diabetic subjects
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Difference of plasma acylcarnitinine profiles after meal load in non-diabetcic and diabetic subjects
Key secondary outcomes
Relation of plasma acylcarnitinine profiles after meal load to HOMA-R
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes who are not treated with insulin.
Healthy volunteers in whom previous blood and urinary glucose tests were normal.
Key exclusion criteria
Subjects using steroid/Subjects using beta blocker or beta stimulant/Subjects taking protein and fat restriction/Subjects with fever or inflammation/Subjects with malignancy/Pregnant subjects/Subjects who consume large amounts of alcohol/Subjects who cannot bear resting position/Subjects with dementia/Subjects with disability in daily activity
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shimpei Fujimoto |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Diabetes and Clinical Nutrition
Zip code
Address
54 Shogoin Kawahara-cho, Sakyo-tu, Kyoto 606-8507
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Diabetes and Clinical Nutrition
Zip code
Address
TEL
Homepage URL
fujimoto@metab.kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Diabetes and Clinical Nutrition, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Project for Biosimulation from the Ministry of Education, Culture, Sports, Science and Technology of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
京都大学医学部附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2010 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | 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
Plasma acylcarnitinine profiles after meal load are compared in non-diabetcic and diabetic subjects. Relation of plasma acylcarnitinine to HOMA-R is analyzed.
Management information
Registered date
| 2010 | Year | 03 | Month | 07 | Day |
Last modified on
| 2010 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003991
