UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004746 |
|---|---|
| Receipt number | R000005651 |
| Scientific Title | Effect of a DPP-4 inhibitor on vascular endothelial function in type 2 diabetic patients |
| Date of disclosure of the study information | 2010/12/20 |
| Last modified on | 2012/07/18 15:05:13 |
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Basic information
Public title
Effect of a DPP-4 inhibitor on vascular endothelial function in type 2 diabetic patients
Acronym
Effect of a DPP-4 inhibitor on vascular endothelial function
Scientific Title
Effect of a DPP-4 inhibitor on vascular endothelial function in type 2 diabetic patients
Scientific Title:Acronym
Effect of a DPP-4 inhibitor on vascular endothelial function
Region
| Japan |
Condition
Condition
Type 2 diabetic patients
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effects of the DPP-4 inhibitor, sitagliptin, on vascular endothelial function measured by flow-mediated dilatation (FMD)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FMD (Flow mediated dilation)
Key secondary outcomes
HbA1c , FPG, 1,5-AG, glycated albumin, C-peptide, Reactive Oxygen Metabolites (ROMs), adiponectin
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
DPP-4 inhibitor
Interventions/Control_2
Standard treatment
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
1) Type 2 diabetic patients
2) Patients treated with none or metformin alone or sulfonylureas alone over 12 weeks prior to the study
3) Patients with written informed consent
Key exclusion criteria
1) Patients with contraindications to sitagliptin use
2) The patient under insulin treatment
3) The patient under alpha-GI or Gulinide treatment
4) Women who are pregnant, possibly pregnant, or are breastfeeding
5) Patients who are determined by the lead principal investigator or contributing investigators to be unsuitable
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenzo Ohba |
Organization
Nippon Medical School Hospital
Division name
Geriatric Medicine
Zip code
Address
1-1-5, Sendagi Bunkyo-ku, Tokyo, Japan
TEL
03-3822-2131
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunari Suzuki |
Organization
Nippon Medical School Hospital
Division name
Geriatric Medicine
Zip code
Address
1-1-5, Sendagi Bunkyo-ku, Tokyo, Japan
TEL
03-3822-2131
Homepage URL
Sponsor or person
Institute
Nippon Medical School Department of Medicine
Division of Cardiology, Hepatology,Geriatrics and Integrated Medicine
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School Department of Medicine
Division of Cardiology, Hepatology,Geriatrics and Integrated 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
| 2010 | Year | 12 | Month | 20 | 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 | 03 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 17 | Day |
Last modified on
| 2012 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005651
