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Name
UMIN ID

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000048606
Receipt No. R000054028
Scientific Title Exploring Mechanistic Study: Potential of Luseogliflozin on Restoration of Ketone Energetics in Diabetic Patients with Coronary Artery Disease
Date of disclosure of the study information 2022/08/06
Last modified on 2022/08/05

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Basic information
Public title Exploring Mechanistic Study: Potential of Luseogliflozin on Restoration of Ketone Energetics in Diabetic Patients with Coronary Artery Disease
Acronym EXPLORE-CAD
Scientific Title Exploring Mechanistic Study: Potential of Luseogliflozin on Restoration of Ketone Energetics in Diabetic Patients with Coronary Artery Disease
Scientific Title:Acronym EXPLORE-CAD
Region
Japan

Condition
Condition Ischemic heart disease with diabetes
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 In this study, the basic question "Does the use of SGLT2 inhibitors cause changes in traits mediated by ketone metabolism?" Was raised while keeping in mind the multifaceted effects of ketone bodies. The presence or absence of changes will be verified by observational studies.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Phenotypic changes through ketone body metabolism
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
60 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria Among type 2 diabetic patients who have decided to receive luseogliflozin, those who meet the following criteria are targeted.
1. Patients who have given written consent to participate in this study
2. Persons with ischemic heart disease (angina / asymptomatic myocardial ischemia).
3. Men and women aged 60 to 85 at the time of consent
Key exclusion criteria 1. Those whose symptoms are not stable (acute myocardial infarction / unstable angina)
2. Patients with type 1 diabetes
3. Patients who require glycemic control with insulin preparations (severe ketosis, diabetic coma or precoma, severe infections, before and after surgery, patients with severe trauma, etc.)
4. Patients with severe hepatic dysfunction (liver dysfunction equivalent to Child-Pugh classification C)
5. Patients with IV heart failure symptoms according to NYHA functional classification
6. Patients with BMI less than 18.5 kg / m2, malnourished or starved
7. Patients with a history of hypersensitivity to the study drug
8. Other patients who the investigator deems inappropriate for this study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Tstujita
Middle name
Last name Kenichi
Organization Kumamoto University
Division name Cardiovascular Medicine
Zip code 860-8556
Address 1-1-1 Honjo, Kumamoto City, Kumamoto, JAPAN, Kumamoto City,
TEL 096-373-5175
Email tsujita@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name Arima
Middle name
Last name Yuichiro
Organization IRCMS
Division name Developmental Cardiology
Zip code 860-0811
Address 2-2-1 Honjo, Kumamoto City, Kumamoto, JAPAN, Kumamoto City,
TEL 096-373-6883
Homepage URL
Email arimay@kumamoto-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Kumamoto University
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kumamoto University
Address 1-1-1 Honjo, Kumamoto city, Kumamoto
Tel 096-373-5657
Email ski-shien@jimu.kumamoto-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
2022 Year 08 Month 06 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
2022 Year 01 Month 24 Day
Date of IRB
2022 Year 01 Month 24 Day
Anticipated trial start date
2022 Year 04 Month 04 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information April 2022; Start enrolling

Management information
Registered date
2022 Year 08 Month 05 Day
Last modified on
2022 Year 08 Month 05 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054028

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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