UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040009 |
|---|---|
| Receipt number | R000045602 |
| Scientific Title | Effect of pemafibrate on hemorheology in microvessels in patients with hypertriglyceridemia associated with type 2 diabetes mellitus or metabolic syndrome |
| Date of disclosure of the study information | 2020/04/08 |
| Last modified on | 2024/11/27 11:33:47 |
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Basic information
Public title
Effect of pemafibrate on hemorheology in microvessels in patients with hypertriglyceridemia associated with type 2 diabetes mellitus or metabolic syndrome
Acronym
Effect of pemafibrate on hemorheology in patients with hypertriglycemiaEffect of pemafibrate on hemorheology in patients with hypertriglycemia
Scientific Title
Effect of pemafibrate on hemorheology in microvessels in patients with hypertriglyceridemia associated with type 2 diabetes mellitus or metabolic syndrome
Scientific Title:Acronym
Effect of pemafibrate on hemorheology in patients with hypertriglycemia
Region
| Japan |
Condition
Condition
metabolic syndrome, Hypertriglycdimia, Diabetes mellitus
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our working hypothesis is that pemafibrate reduces plasma levels of triglyceride and free fatty acid and suppresses leukocyte activation in microvessels and improves blood fluidity in patients with hypertriglyceridemia associated with type 2 diabetes or metabolic syndrome.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes from baseline in whole blood transit time in micro channel array flow analyzer(MCFAN) at 16 weeks)
Key secondary outcomes
Change from baseline in whole blood transit time in MCFAN at 8 weeks
Leukocyte activation index (adhesive leukocyte count, difference in whole blood transit time between heparin blood collection and heparin + EDTA2Na blood collection)
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients who are visiting or planning to visit Dokkyo Medical University Nikko Medical Center
2) Patients who are at least 20 years old at the time of obtaining consent
3) Patients who have been diagnosed with type 2 diabetes on administration of pemafibrate and have 6% to 10% HbA1c and have not changed their diabetes treatment in the past 4 weeks or have metabolic syndrome
4) Fasting TG 150 mg / dL equivalent or higher within 2 weeks before pemafibrate administration
5) Whole blood transit time (correction value) in MCFAN within 2 weeks before pemafibrate administration 45 seconds or slower
MCFAN of whole blood transit time (correction) within 2 weeks before administration of pemafibrate, plus all blood transit time (correction) within 6 weeks before administration including 2-6 weeks before administration of pemafibrate Transit time of whole blood (correction value)
6) Pemafibrate newly prescribed or scheduled to be prescribed
7) Patients who have given their written consent to participate in the study
Metabolic syndrome is defined when the waist circumference (abdominal waist circumference) is 85 cm for men and 90 cm or more for women, and two or more of blood pressure, blood sugar, and lipids are out of the standard values. (Table below, Journal of the Japanese Society of Internal Medicine; 2005; 94: 188-203.)
Required items (visceral fat accumulation)
Waist circumference male 85 cm or more
Female 90 cm or more
Visceral fat area Equivalent to 100 cm2 for both men and women
Selection item
Out of 3 items
2 or more items
1.Hypertriglyceridemia is 150 mg / dL or more and or
Low HDL cholesterol 40 mg / dL or more
2. systolic (maximum) blood pressure 130 mmHg or more
And or diastolic (minimum) blood pressure 85 mmHg or more
3.Fasting hyperglycemia 110 mg / dL
Key exclusion criteria
Patients judged by the Principal Investigator or Investigator (hereinafter referred to as the Principal Investigator, etc.) to be inappropriate for participation in the research
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Yasu |
Organization
Dokkyo Medical University Nikko Medical Center
Division name
Department of cardiology medicine and nephrology
Zip code
321-1298
Address
632 Takatoku, Nikko City, Tochigi Prefecture
TEL
0288-23-7000
tyasu@dockyomed.ac.jp
Public contact
Name of contact person
| 1st name | Takanori |
| Middle name | |
| Last name | Yasu |
Organization
Dokkyo Medical University Nikko Medical Center
Division name
Department of cardiology medicine and nephrology
Zip code
321-1298
Address
632 Takatoku, Nikko City, Tochigi Prefecture
TEL
0288-23-7000
Homepage URL
tyasu@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University Nikko Medical Center
Department of cardiology medicine and nephrology
Institute
Department
Personal name
Funding Source
Organization
Kowa Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Dokkyo Medical University Nikko Medical CenterBioethics Committee
Address
632 takatoku, Nikko City, Tochigi Prefecture
Tel
0288-23-7000
rinshokenkyu@dokkyomed.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 | 04 | Month | 08 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_view.cgi?recptno=R000045602
Publication of results
Published
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_view.cgi?recptno=R000045602
Number of participants that the trial has enrolled
50
Results
PI
Results date posted
| 2024 | Year | 11 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
1) Patients who are visiting or planning to visit Dokkyo Medical University Nikko Medical Center
2) Patients who are at least 20 years old at the time of obtaining consent
3) Patients who have been diagnosed with type 2 diabetes on administration of pemafibrate and have 6% to 10% HbA1c and have not changed their diabetes treatment in the past 4 weeks or have metabolic syndrome
4) Fasting TG 150 mg / dL equivalent or higher within 2 weeks before pemafibrate administration
5) Whole blood transit time (correction value) in MCFAN within 2 weeks before pemafibrate administration 45 seconds or slower
MCFAN of whole blood transit time (correction) within 2 weeks before administration of pemafibrate, plus all blood transit time (correction) within 6 weeks before administration including 2-6 weeks before administration of pemafibrate Transit time of whole blood (correction value)
6) Pemafibrate newly prescribed or scheduled to be prescribed
7) Patients who have given their written consent to participate in the study
Metabolic syndrome is defined when the waist circumference (abdominal waist circumference) is 85 cm for men and 90 cm or more for women, and two or more of blood pressure, blood sugar, and lipids are out of the standard values. (Table below, Journal of the Japanese Society of Internal Medicine; 2005; 94: 188-203.)
Required items (visceral fat accumulation)
Waist circumference male 85 cm or more
Female 90 cm or more
Visceral fat area Equivalent to 100 cm2 for both men and women
Selection item
Out of 3 items
2 or more items
1.Hypertriglyceridemia is 150 mg / dL or more and or
Low HDL cholesterol 40 mg / dL or more
2. systolic (maximum) blood pressure 130 mmHg or more
And or diastolic (minimum) blood pressure 85 mmHg or more
3.Fasting hyperglycemia 110 mg / dL
Participant flow
2020/4/8 First person consent acquisition / examination start
2020/1/6 Number of consent holders: 25
2021/10/14 50th(final)concent obtained
2022/2/7 End of observation Consent withdrawal number of people 1 Discontinuance number of people 2
Adverse events
1 Constipation
2 Backache
3 Backache Gastric reflux
4 Left lower extremity compartment syndrome
Outcome measures
Changes from baseline in whole blood transit time in micro channel array flow analyzer(MCFAN) at 16 weeks)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 03 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Collect data performed within the range of daily medical care 8 weeks and 16 weeks after administration
Dosing period 16 weeks 0.1 mg / day twice daily
Management information
Registered date
| 2020 | Year | 03 | Month | 31 | Day |
Last modified on
| 2024 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045602
