UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004881 |
|---|---|
| Receipt number | R000005783 |
| Scientific Title | DPP-4(Dipeptidyl peptidase-4) inhibitor Sitagliptin Phosphate Hydrate study to the inhibition of extension atherosclerosis |
| Date of disclosure of the study information | 2011/01/14 |
| Last modified on | 2011/01/15 11:07:38 |
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Basic information
Public title
DPP-4(Dipeptidyl peptidase-4) inhibitor Sitagliptin Phosphate Hydrate study to the inhibition of extension atherosclerosis
Acronym
Study of DPP-4 inhibitor for preventing artheriosclerosis
Scientific Title
DPP-4(Dipeptidyl peptidase-4) inhibitor Sitagliptin Phosphate Hydrate study to the inhibition of extension atherosclerosis
Scientific Title:Acronym
Study of DPP-4 inhibitor for preventing artheriosclerosis
Region
| Japan |
Condition
Condition
Type2 diabetes mellitus (borderline)
Classification by specialty
| Endocrinology and Metabolism | Vascular surgery | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of DPP-4 inhibitor on atherosclelosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1.serum lipd marker, saccharometabolism marker (HbA1c, fasting blood sugar score, fasting insulin score, adiponectin)
2.Parameters of atherosclerosis (flow-mediated dialatation (FMD), Ankle-brachial index(ABI)/pulse wave velosity(PWV) score, the thickness of carotid artery inner membrane)
3.another points of atherosclerosis (the echo of cartid artery (PI value, RI value))
Key secondary outcomes
1.blod pressure, body weight, waist, BMI
2.liver function test(AST, ALT. g-GTP, LDH)
3.kidney function test(sCr, uCr, BUN, urine Alb)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
intake of DPP-4 inhibitor
Interventions/Control_2
not intake of DPP-4 inhibitor
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Is borderline type2 diabetes mellitus regardless of meal therapy and exercise training more than 1month (2010 Guideline of Diabetes mellitus society) and meet at least following requirement.
1.Diagnosis of borderline type2 diabetes mellitus (75g OGTT 2hours score and FBS score).
2.over the 20 years and under the 85 years. (man or women are not problem.)
3. for the first time, the outpatient who take no diabetic medecine or at least take only one another diabetic medicine(Insuline secretagogue, Biguanide, A-glucosidase inhibitor) more than 6 months.
Key exclusion criteria
1.Has a history of allergy to Sitagliptin Phosphate Hydrate
2.Has a history of severe ketosis, diabetic coma and type1 diabetes mellitus
3.Has a history of severe renal insufficiency (hemodialysis or peritoneal dialysis patients)
4.Has a history of severe infection, perioperative term and severe wound
5.Has a overt systemic disease (liver cirrhosis, thyroid gland disease and nephrotic syndrome and so on)
6.Is not appropriate in the investigators' opinion
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotsugu Kurobe |
Organization
Tokushima University Hospital
Division name
Department of Cardiavascular surgery
Zip code
Address
2-50-1 Kuramoto-cho, Tokushima
TEL
088-633-7851
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokushima University Hospital
Division name
Department of Cardiavascular surgery
Zip code
Address
2-50-1 Kuramoto-cho, Tokushima
TEL
088-633-7851
Homepage URL
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
徳島県/tokushima prefecture
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 01 | Month | 14 | 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 | 01 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | 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
Management information
Registered date
| 2011 | Year | 01 | Month | 14 | Day |
Last modified on
| 2011 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005783
