UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041707 |
|---|---|
| Receipt number | R000047605 |
| Scientific Title | The clinical study investigating the effect of pemafibrate administration on cardiac diastolic function in patients with type 2 diabetes |
| Date of disclosure of the study information | 2020/09/23 |
| Last modified on | 2020/09/09 14:29:43 |
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Basic information
Public title
The clinical study investigating the effect of pemafibrate administration on cardiac diastolic function in patients with type 2 diabetes
Acronym
The effect of pemafibrate on cardiac diastolic function in patients with type 2 diabetes
Scientific Title
The clinical study investigating the effect of pemafibrate administration on cardiac diastolic function in patients with type 2 diabetes
Scientific Title:Acronym
The effect of pemafibrate on cardiac diastolic function in patients with type 2 diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes, Dyslipidemia
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Many studies suggest that left ventricle diastolic dysfunction is one of the earliest cardiac changes in diabetic patients. Diabetic cardiomyopathy possibly occurs as a result of the dysregulated lipid metabolism associated with diabetes, although the mechanism contributing diabetic cardiomyopathy is poorly understood. Our aim is to study the effect of pemafibrate on cardiac diastolic dysfunction leading to diabetic cardiomyopathy. In this study, we are evaluating the effect of pemafibrate using some diastolic function parameters.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Left ventricular inflow blood velocity waveform
(before versus 8-16 weeks after
pemafibrate administration)
Key secondary outcomes
Mitral annulus TDI,
Pulmonary blood flow pressure waveform,
AST, ALT, ALP, gammaGTP, Triglyceride, Free Fatty Acid, BNP(before versus 8-16 weeks after
pemafibrate administration)
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
| 25 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients who is diagnosed type 2 diabetes and
hypertriglyceridemia (reference value: fasting triglyceride above 150mg/dL).
2)Patients who will be administered with pemafibrate.
3)Patients who understand this study and agree to written consent to participating in it based on sufficient explanations.
Key exclusion criteria
1) Who has a history of fibrate exposure within 6 months.
2) Who suffers from atrial fibrillation.
3) Who is judged by the investigators to be inappropriate for this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yasuharu |
| Middle name | |
| Last name | Ohta |
Organization
Yamaguchi University, Graduate School of Medicine
Division name
Division of Endocrinology, Metabolism, Hematological Science and Therapeutics, Department of Bio-Signal Analysis
Zip code
755-8505
Address
1-1-1, Minami Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL
0836-22-2251
yohta@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuharu |
| Middle name | |
| Last name | Ohta |
Organization
Yamaguchi University, Graduate School of Medicine
Division name
Division of Endocrinology, Metabolism, Hematological Science and Therapeutics
Zip code
755-8505
Address
1-1-1, Minami Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL
0836-22-2251
Homepage URL
yohta@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University, Graduate School of Medicine, Division of Endocrinology, Metabolism, Hematological Science and Therapeutics, Department of Bio-Signal Analysis
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi University, Graduate School of Medicine, Division of Endocrinology, Metabolism, Hematological Science and Therapeutics, Department of Bio-Signal Analysis
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center For Clinical Research, Yamaguchi University Hospital
Address
Minami Kogushi, Ube, Yamaguchi 755-8505, Japan
Tel
0836-22-2428
me223@yamaguchi-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
| 2020 | Year | 09 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Comparison of evaluation value before versus 8-16 weeks after 0.2mg pemafibrate administration
Management information
Registered date
| 2020 | Year | 09 | Month | 07 | Day |
Last modified on
| 2020 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047605
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/09/11 | パルモ計画書 延長用(2).docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2023/09/11 | パルモ説明文書ver2.1.(延長用）docx.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/09/11 | ペマフィブラート臨床研究データ.n=14(前のみ16）(エコー）JES1(1).xlsx |
