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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000004881
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Tokushima University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005783

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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