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Effect of pemafibrate on hemorheology in microvessels in patients with hypertriglyceridemia associated with type 2 diabetes mellitus or metabolic syndrome

Effect of pemafibrate on hemorheology in microvessels in patients with hypertriglyceridemia associated with type 2 diabetes mellitus or metabolic syndrome - Effect of pemafibrate on hemorheology in patients with hypertriglycemia

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000040009
Enrollment
50
Registered
2020-04-08
Start date
2020-04-08
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metabolic syndrome, Hypertriglycdimia, Diabetes mellitus

Interventions

None listed

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Changes from baseline in whole blood transit time in micro channel array flow analyzer(MCFAN) at 16 weeks)

Secondary

MeasureTime frame
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)

Countries

Japan

Contacts

Public ContactTakanori Yasu

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

tyasu@dokkyomed.ac.jp0288-23-7000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026