UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002034 |
|---|---|
| Receipt number | R000002485 |
| Scientific Title | Relationships between serum osteocalcin versus serum glucose and lipids levels and atherosclerosis in type 2 diabetes mellitus |
| Date of disclosure of the study information | 2009/06/02 |
| Last modified on | 2009/06/02 19:44:48 |
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Basic information
Public title
Relationships between serum osteocalcin versus serum glucose and lipids levels and atherosclerosis in type 2 diabetes mellitus
Acronym
Relationships between serum osteocalcin versus serum glucose and lipids levels and atherosclerosis in type 2 diabetes mellitus
Scientific Title
Relationships between serum osteocalcin versus serum glucose and lipids levels and atherosclerosis in type 2 diabetes mellitus
Scientific Title:Acronym
Relationships between serum osteocalcin versus serum glucose and lipids levels and atherosclerosis in type 2 diabetes mellitus
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationships between serum osteocalcin versus serum glucose and lipids levels and atherosclerosis
Basic objectives2
Others
Basic objectives -Others
a observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
whether or not the signifiant relationships between serum osteocalcin versus serum glucose and lipids levels and atherosclerosis are found
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes mellitus
Key exclusion criteria
Nobody had hepatic or renal dysfunction or nutritional derangements.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ippei Kanazawa |
Organization
Shimane University Faculty of Medicine
Division name
Internal Medicine 1
Zip code
Address
89-1 Enya-cho, Izumo, Shimane
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shimane University Faculty of Medicine
Division name
Internal Medicine 1
Zip code
Address
89-1 Enya-cho, Izumo, Shimane
TEL
Homepage URL
ippei.k@med.shimane-u.ac.jp
Sponsor or person
Institute
Internal Medicine 1, Shimane University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
self funding
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
| 2009 | Year | 06 | Month | 02 | 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
Serum osteocalcin levels are associated with glucose and lipid metabolism as well as atherosclerosis in type 2 diabetes mellitus
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
| 2007 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 05 | Month | 01 | Day |
Other
Other related information
Multiple regression analysis showed that changes in osteocalcin negatively correlated with baseline triglyceride, and positively with baseline plaque score. Baseline serum osteocalcin level negatively correlated with changes in triglyceride, and positively with changes in HDL-cholesterol. Changes in osteocalcin negatively correlated with changes in HbA1c and plaque score.
Management information
Registered date
| 2009 | Year | 06 | Month | 02 | Day |
Last modified on
| 2009 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002485
