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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040009
Receipt No. 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 2020/04/02

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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 321-2593
Address 632 Takatoku, Nikko City, Tochigi Prefecture
TEL 0288-76-1515
Email 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 321-2593
Address 632 Takatoku, Nikko City, Tochigi Prefecture
TEL 0288-76-1515
Homepage URL
Email tyasu@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University Nikko Medical Center
Department of cardiology medicine and nephrology
Institute
Department

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 0288-76-1515
Email 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
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 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
2020 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045602

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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