UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003526 |
|---|---|
| Receipt number | R000004279 |
| Scientific Title | Correlation between monocyte count and progression of atherosclerosis in type2 diabetes |
| Date of disclosure of the study information | 2010/04/23 |
| Last modified on | 2013/12/29 18:39:31 |
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Basic information
Public title
Correlation between monocyte count and progression of atherosclerosis in type2 diabetes
Acronym
Diabetes-Monocyte study
Scientific Title
Correlation between monocyte count and progression of atherosclerosis in type2 diabetes
Scientific Title:Acronym
Diabetes-Monocyte study
Region
| Japan |
Condition
Condition
type2 diabetic patients
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to investigate the correlation between monocyte count and and atherosclerotic markers including intra-medial thickness of carotid artery in type2 diabetic patients.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1: correlation between monocyte count and IMT.
2: correlation between monocyte count and PWV.
Key secondary outcomes
1: correlation between leukocyte count and several factors as follow:TC, LDL, HDL-C, TG, HbA1c, HOMA-IR, TNFalpha, IL-6, adiponectin, solble insulin receptor.
2: correlation between leukocyte count and IMT.
3: correlation between leukocyte count and PWV.
4: correlation between leukocyte count and several factors as follow:TC, LDL, HDL-C, TG, HbA1c, HOMA-IR, TNFalpha, IL-6, adiponectin, solble insulin receptor.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Type2 Diabetic patients
Key exclusion criteria
1.patients with infectious disease
2.patients with liver disfunction
3.patients with blood disease
4.Pregnant woman
5.other patients who are judged as unsuitable by investigators
Target sample size
360
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Matsumura |
Organization
Faculty of Life Sciences, Kumamoto University
Division name
Department of Metabolic Medicine
Zip code
Address
1-1-1 Honjo, Kumamoto, 860-8556, Japan.
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Matsumura |
Organization
Faculty of Life Sciences, Kumamoto University
Division name
Department of Metabolic Medicine
Zip code
Address
TEL
096-373-5169
Homepage URL
takeshim@gpo.kumamoto-u.ac.jp
Sponsor or person
Institute
Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
none
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
熊本大学医学部附属病院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2010 | Year | 01 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
| 2013 | Year | 12 | Month | 18 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 20 | Day |
Other
Other related information
Primary factors:
It is usful to clarify the correlation between monocyte count and atherosclerotic markers.
Resuls:
It is expected that there is a correlation between monocyte count and atherosclerotic markers.
This study is a retrospective study.
This study introduces the random sampling.
Management information
Registered date
| 2010 | Year | 04 | Month | 23 | Day |
Last modified on
| 2013 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004279
