UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006432 |
|---|---|
| Receipt number | R000007634 |
| Scientific Title | Early treatment of glucose toxicity with sitagliptin prevent progression of arteriosclerosis in cardiovascular disease patients |
| Date of disclosure of the study information | 2011/09/29 |
| Last modified on | 2011/09/29 07:20:52 |
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Basic information
Public title
Early treatment of glucose toxicity with sitagliptin prevent progression of arteriosclerosis in cardiovascular disease patients
Acronym
SPARC study
Scientific Title
Early treatment of glucose toxicity with sitagliptin prevent progression of arteriosclerosis in cardiovascular disease patients
Scientific Title:Acronym
SPARC study
Region
| Japan |
Condition
Condition
more than 50% coronary artery stenosis with diabetes, including impaired glucose tolerance
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It has also been reported that a fair percentage of patients with some cardiovascular diseases have abnormal glucose tolerance such as diabetes mellitus and impaired glucose tolerance, and that those patients have an ominous prognosis.
The aim of this study is to examine how the early improvement of glucose toxicity with administration of sitagliptin, hyperglycemia improving drug, to those cases, affects the development of cardiovascular events such as recurrence and deteriorating of angina and anti-atherogenic action by echo finding.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
incidence of cardiovascular events: new onset myocardial infarction, worsening anginal status and/or angiographic restenosis
Carotid intima-medial thickness(IMT)
Key secondary outcomes
1-1)Ultrasonic echo cardiography(IVS; Interventricular Septal Thickness, EF; Ejection Fraction, E/A, LVDd; Left Ventricular Diastolic dimension)
2-1)HbA1c
2-2)IRI
2-3)blood glucose levels
2-4)HOMA-R,HOMA-beta
3)Plasma lipid profile
4)BNP
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Sitagliptin is initiated with 50mg/time, 1 times/day, and increased to 100mg/time after examining tolerability if there is no enough therapeutic effect. However, the dosage shall be determined by their personal doctors.
Interventions/Control_2
Diet and exercise
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
Patients who were found at catheterization test to have more than 50 % of stenosis, diagnosed with diabetic (including IGT) at 75g oral glucose tolerance test : 140mg/dl or more, HbA1c : less than 6.5%) are assigned to groups with or without Sitagliptin for comparison.
Subjects who are hyperlipidemic or who require administration of statin.
Key exclusion criteria
Any subject who applies to the article below shall be excluded.
1) Patients on oral antidiabetic or insulin preparation
2) Patients with a history of ileus or undergone laparotomy
3) Patients with severe liver dysfunction or renal dysfunction
4) Patients with serious case of ketosis or diabetical coma, or precoma
5) Patients with severe infection disease, or in the perioperative period, or with extreme trauma
6)Patient who caused myocardial infarction within the past six months
7) Patients with a history of sensitivity to Sitagliptin
8) Pregnant or possibly pregnant women
9) Patients judged by the investigator/subinvestigator to be ineligible for some other reason
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Watarai |
Organization
Cardiovascular Center,Anjo Kosei Hospital
Division name
Division of Cardiology
Zip code
Address
28 Higashi-hirokute, Anjyo-cho, Anjyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Cardiovascular Center,Anjo Kosei Hospital
Division name
Division of Cardiology
Zip code
Address
TEL
0566-75-2111
Homepage URL
Sponsor or person
Institute
Cardiovascular Center,Anjo Kosei Hospital
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
愛知県厚生農業協同組合連合会 安城更生病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 29 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 29 | Day |
Last modified on
| 2011 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007634
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| Registered date | File name |
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