UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004656 |
|---|---|
| Receipt number | R000005547 |
| Scientific Title | Serum PAI-1 levels in type 2 diabetic patients on sitagliptin treatment |
| Date of disclosure of the study information | 2010/12/06 |
| Last modified on | 2012/06/02 14:57:03 |
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Basic information
Public title
Serum PAI-1 levels in type 2 diabetic patients on sitagliptin treatment
Acronym
PAI-1 in T2DM on sitagliptin
Scientific Title
Serum PAI-1 levels in type 2 diabetic patients on sitagliptin treatment
Scientific Title:Acronym
PAI-1 in T2DM on sitagliptin
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of sitagliptin and other treatment without DPP-4 inhibitor for serum PAI-1 levels in type 2 diabetic patient
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PAI-1
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1> type 2 diabetic patient treated with sitagliptin for more 2 months
2> type 2 diabetic patient treated without DPP-4 inhibitors
Key exclusion criteria
1> patient treated with insulin injection
2> patient treated with GLP-1 receptor agonists
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Terauchi |
Organization
Yokohama City University,
Graduate School of Medicine
Division name
Dept. of Endocrinology and Metabolism
Zip code
Address
3-9, Fuku-ura, Kanazawa-ku, Yokohama, 236-0004, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Shirakawa |
Organization
Yokohama City University, Graduate School of Medicine
Division name
Dept. of Endocrinology and Metabolism
Zip code
Address
TEL
045-787-2639
Homepage URL
Sponsor or person
Institute
Yokohama City University,
Graduate School of Medicine
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
横浜市立大学附属病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/22497969
Number of participants that the trial has enrolled
Results
We investigated a possible association between serum plasminogen activator inhibitor-1 (PAI-1) levels and renal dysfunction in 124 type 2 diabetes patients. Multiple linear regression analyses indicated that the PAI-1 levels were significantly inversely correlated with estimated glomerular filtration rate (eGFR) independent of albuminuria, BMI, LDL-C, and triglyceride.
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 | 11 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 03 | Month | 01 | Day |
Other
Other related information
Evaluate the serum PAI-1 concentration in type 2 diabetic patient treated with sitagliptin.
Management information
Registered date
| 2010 | Year | 12 | Month | 02 | Day |
Last modified on
| 2012 | 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=R000005547
