Effect of EPA/DHA combination therapy on LDL particle size in patients with hyperlipidemia and type 2 diabetes taking HMG-CoA reductive enzyme inhibitors and DPP-4 inhibitors.

Effect of EPA/DHA combination therapy on LDL particle size in patients with hyperlipidemia and type 2 diabetes taking HMG-CoA reductive enzyme inhibitors and DPP-4 inhibitors. - Effect of EPA/DHA combination therapy on LDL particle size

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013776

Enrollment

Registered

2014-04-21

Start date

2013-11-20

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

Type 2 diabetes mellitus with hyperlipidemia

Interventions

EPA/DHA formulation (1) Brand name : Lotriga granulated capsule 2g (2) Generic name : Omega-3 fatty acids ethyl

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Type 2 diabetes mellitus patients, those who received both DPP IV inhibitors and HMG-CoA inhibitors, and have HbA1c level of < 8.0% (NGSP) and LDL-C level of < 120mg/dl. 2) Patients have fasting TG level of >=150mg/dl, those who received diet and exercise therapy more than 12 weeks, and clinically determined to have an additional pharmacotherapy. 3) Patients aged from 20 to 80 years at the baseline 4) Patients provided written informed consent

Exclusion criteria

Exclusion criteria: Among the patients, those who judged as the criteria below are not eligible for the trial. 1) TG>=1000mg/dl or HDL-C =<30mg/dl 2) Received Fibrates 3) Received Pioglitazone 4) 0mega-3 fatty acids contraindication status (Bleeding: Hemophilia, Peptic ulcer, etc) 5) Hypersensitive history to EPA formulation or EPA/DHA formulation 6) Familial combined hyper low-density lipoproteinaemia 7) Type 1 diabetes mellitus 8) Severe diabetic ketosis, diabetic coma or total coma within 6 months 9) Severe infectious disease, before or after surgery, and sever trauma 10) Moderate renal dysfunction (Serum creatinine (mg/dl): male, 1.5=<; female, 1.3=<) 11) Occurrence of stroke, AMI, and the other severe cardiovascular events that lead patients to be hospitalized within 6 months 12) Concomitant malignant disease 13) Pregnant, lactating, possibly pregnant or planning to become pregnant women 14) Without written informed consent 15) Patients considered as inadequate by the principal investigator

Design outcomes

Primary

Measure	Time frame
The change of parameters in LDL particle size (for 12 weeks with administration of EPA/DHA)	—

Secondary

Measure	Time frame
The change of - LDL particle concentration - LDL particle number - Cholesterol and triglyceride concentration, free glycerol concentration - Other cholesterol and triglyceride particle sizes - Other cholesterol and triglyceride particle concentration - Other cholesterol and triglyceride particle number - Lipoprotein Insulin Resistance Score (LPIR) - Inflammation Marker (GlycA) - EPA/AA ratio, DHA/AA ratio - Lipid profile (LDL-C, HDL-C, TG, etc) - HbA1c - Fasting blood glucose - Safety assessment (Renal function, Liver function, etc)	—

Measure

Time frame

The change of - LDL particle concentration - LDL particle number - Cholesterol and triglyceride concentration, free glycerol concentration - Other cholesterol and triglyceride particle sizes - Other cholesterol and triglyceride particle concentration - Other cholesterol and triglyceride particle number - Lipoprotein Insulin Resistance Score (LPIR) - Inflammation Marker (GlycA) - EPA/AA ratio, DHA/AA ratio - Lipid profile (LDL-C, HDL-C, TG, etc) - HbA1c - Fasting blood glucose - Safety assessment (Renal function, Liver function, etc)

—

Countries

Japan

Contacts

Public ContactMasaya Koshizaka

Chiba University Hospital Diabetes, Metabolism and Endocrinology

overslope@chiba-u.jp043-222-7171

Outcome results

None listed

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