UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008620 |
|---|---|
| Receipt number | R000010058 |
| Scientific Title | The impact of DPP-4 inhibitor on daily glucose profile and coronary plaque character in impaired glucose tolerance patients with coronary artery disease |
| Date of disclosure of the study information | 2012/08/06 |
| Last modified on | 2022/03/15 18:50:33 |
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Basic information
Public title
The impact of DPP-4 inhibitor on daily glucose profile and coronary plaque character in impaired glucose tolerance patients with coronary artery disease
Acronym
the impact of Vildagliptin On daily Glucose profile and coronary plaqUE character in impaired glucose tolerance patients with coronary artery disease:VOGUE-KOBE
Scientific Title
The impact of DPP-4 inhibitor on daily glucose profile and coronary plaque character in impaired glucose tolerance patients with coronary artery disease
Scientific Title:Acronym
the impact of Vildagliptin On daily Glucose profile and coronary plaqUE character in impaired glucose tolerance patients with coronary artery disease:VOGUE-KOBE
Region
| Japan |
Condition
Condition
patients with coronary artery disease and impaired glucose tolerance (IGT)
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of vildagliptin versus conventional treatment without DDP-4 inhibitor on daily glucose profile analyzed by 24-hour continuous glucose monitoring system and coronary plaque character using coronary imaging devices in IGT patients with coronary artery disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in coronary plaque character analyzed by coronary angiography, intravascular ultrasound, and optical coherence tomography, and daily glucose profile analyzed by 24-hour continuous glucose monitoring system before and after 6 months treatment with vildagliptin in comparison with conventional treatment without DPP-4 inhibitor
Key secondary outcomes
1)Changes in the IMT value measured by carotid arterial echography
2)Changes in HbA1c (NGSP) and 75g OGTT (glucose and insulin levels after glucose load)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
Vildagliptin group:start with Vildagliptin 50 mg/day
Interventions/Control_2
Diet and exercise without DPP-4 inhibitotr
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)In patients undergoing PCI, "untreated IGT" and "2-hour plasma/serum glucose level: 140mg/dL to 199mg/dL in a 75g oral glucose tolerance test"
2)LDL-chol < 100mg/dl in patients without statin. LDL-chol < 120mg/dl in patients with statin.
3)patients between 20 and 80 years old
4)Written consent for participation in the study
Key exclusion criteria
Patients meeting one of the following conditions will be excluded:
1)under treatment of diabetes, or type 1 diabetes
2)severe liver dysfunction
3)severe renal dysfunction
4)severe heart failure) (NYHA/New York Heart Association stage III or severer)
5)Malignancies or other diseases with poor prognosis
6) pregnant, lactating, and possibly pregnant women and those planning to become pregnant
7) past medical history of hypersensitivity to investigational drugs
8) judged as ineligible by clinical investigators
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Toshiro |
| Middle name | |
| Last name | Shinke |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
+81-78-382-5846
shinke@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshiro |
| Middle name | |
| Last name | Shinke |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
+81-78-382-5846
Homepage URL
shinke@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Division of diabetes and metabolism, Kobe University Graduate School of Medicine
Hyogo Brain and Heart Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Graduate School of Medicine
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
Tel
+81-78-382-5846
shinke@med.showa-u.ac.jp
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
| 2012 | Year | 08 | Month | 06 | Day |
Related information
URL releasing protocol
https://bmccardiovascdisord.biomedcentral.com/track/pdf/10.1186/s12872-021-01902-0.pdf
Publication of results
Published
Result
URL related to results and publications
https://bmccardiovascdisord.biomedcentral.com/articles/10.1186/s12872-021-01902-0
Number of participants that the trial has enrolled
24
Results
Vildagliptin could reduce the MAGE at 6 months and may be associated with the decreased lipid arc and increased minimum FCT of the coronary plaques in CAD patients with IGT as compared with the control group.
These findings may represent its potential stabilization effect on coronary plaques, which are characteristic in this patient subset.
Results date posted
| 2022 | Year | 03 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients included in this study satisfied the following criteria: (1) scheduled to undergo percutaneous coronary intervention (PCI) for stable CAD with an untreated IGT(2) under lipid-lowering management; low-density lipoprotein cholesterol<120 mg/dl with statin administration, and<100 mg/dl without statin administration, (3) between 20 and 80 years old, and 4) having provided written informed consent for participation in the study.
Participant flow
a multicenter, open-label, randomized
controlled trial at two institutes in Japan
Adverse events
nothing
Outcome measures
In this trial protocol, the primary endpoint was changes in coronary plaque characteristics, such as the minimum FCT and lipid arc detected by OCT between baseline and
6 months after intervention, and those in the MAGE. The following OCT parameters were determined for analysis: the minimum lumen area, lipid length, lipid mean arc, and minimum FCT for quantitative variables.
As outcomes of glycemic metabolic variables, the MAGE, time in hyperglycemia/ hypoglycemia, and mean, maximum, and minimum blood glucose levels were measured. As clinical outcome, cardiac death, myocardial infarction (MI), cerebral infarction, target
lesion revascularization (TLR), and target vessel revascularization (TVR) were set.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2012 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 05 | Day |
Last modified on
| 2022 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010058
