UMIN-CTR Clinical Trial

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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