UMIN-CTR Clinical Trial

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
Email	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
Email	shinke@med.kobe-u.ac.jp

Sponsor
Institute	Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010058