UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048606 |
|---|---|
| Receipt number | 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 17:08:08 |
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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
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
arimay@kumamoto-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Kumamoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054028
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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