UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of the relationship between coronary plaque findings and indices of glycemic variability
Title of the study (Brief title)	Kobe variability 2 study
Region	Japan

Condition
Condition	coronary artery disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the relationship between coronary plaque findings and indices of glycemic variability on CGM
Basic objectives2	Others
Basic objectives -Others	To deterimin the most reliable index of glycemic variability to predict dangerous plaque
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To deterimin the most reliable index of glycemic variability to predict dangerous plaque
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	The patient who 1)LDL-Chol<120 mg/dl under statin adminsitration or < 100 mg/dl under other treatment for dislipidemia, including lifestyle modification
Key exclusion criteria	1) PCI for acute coronary syndrome 2) unsuitable anatomy of virtual histology(VH) or optical coherence tomography(OCT)-IVUS 3) poor imaging of VH or OCT-IVUS 4) hemodialysis 5) inflammatory disease 6) shock or low cardiac output 7) malignancy 8) When consecutive 48-hour data are not provided from CGM
Target sample size	53

Research contact person
Name of lead principal investigator	KazuhikoSakaguchi
Organization	Kobe University school of medicine
Division name	Devision of diabetes and endocrinology
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017
TEL	078-382-5861
Email	kzhkskgc@med.kobe-u.ac.jp

Public contact
Name of contact person	KazuhikoSakaguchi
Organization	Kobe University school of medicine
Division name	Devision of diabetes and endocrinology
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017
TEL	078-382-5861
Homepage URL
Email	kzhkskgc@med.kobe-u.ac.jp

Sponsor
Institute	Devision of diabetes and endocrinology, Kobe University school of medicine
Institute
Department

Funding Source
Organization	Donation
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 15 Day
Anticipated trial start date	2015 Year 07 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 10 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	To investigate the relationship between coronary plaque vulnetability and indices of glycemic variability [Objectives] Fifty-three consecutive patients who had undergone percutaneous coronary intervention (PCI) for CAD from June 2012 to May 2014 and who fulfilled the inclusion criteria [Data Collection] age, sex, height, weight, medication, durations of diabetes, comorbidities and past histories, family history, smoking, blood pressure laboratory data: LDL-C, TG, HDL-C, FFA, HbA1c, GA, 1,5-AG, BUN, Cre, eGFR, BNP, Hb, CRP LVEF(%) IVUS study: Necrotic core %, Fibrous %, Calcium %, OCT-lipid CGM data: Subcutaneous glucose concentration

Management information
Registered date	2015 Year 07 Month 15 Day
Last modified on	2018 Year 01 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021065