UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005658 |
|---|---|
| Receipt number | R000006686 |
| Scientific Title | Analysis of Serum Fatty Acids Concentrations in Japanese Subjects with Type2 Diabetes |
| Date of disclosure of the study information | 2011/05/26 |
| Last modified on | 2011/05/26 22:38:13 |
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Basic information
Public title
Analysis of Serum Fatty Acids Concentrations in Japanese Subjects with Type2 Diabetes
Acronym
Fatty Acids Levels in Diabetic Patients
Scientific Title
Analysis of Serum Fatty Acids Concentrations in Japanese Subjects with Type2 Diabetes
Scientific Title:Acronym
Fatty Acids Levels in Diabetic Patients
Region
| Japan |
Condition
Condition
Type2 Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the significance of Eicosapentaenoic acid/Arachidonic acid ratio to predict cariovascular events in subjects with diabetes
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fraction of serum fatty acids
Plasma glucose levels
HbA1c
Blood pressure
Heart rate
Serum lipid levels
Urinary albumin excretion
Estimated glomerular filtration rate
Intima media thickness
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients with type2 diabetes
Key exclusion criteria
patients treated with ethyl icosapentate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | DAIJI KAWANAMI |
Organization
Jikei University School of Medicine
Division name
Division of Diabetes, Endocrinology and Metabolism
Zip code
Address
3-25-8 Nishi-Shimbashi Minato-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | DAIJI KAWANAMI |
Organization
Jikei University School of Medicine
Division name
Division of Diabetes, Endocrinology and Metabolism
Zip code
Address
TEL
Homepage URL
daijika@jikei.ac.jp
Sponsor or person
Institute
Division of Diabetes, Endocrinology and Metabolism, Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Diabetes, Endocrinology and Metabolism, Jikei University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 26 | 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
| 2011 | Year | 05 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | 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
Serum Levels of Fatty Acids will be measured in patients with type2 diabetes.
Management information
Registered date
| 2011 | Year | 05 | Month | 26 | Day |
Last modified on
| 2011 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006686
