Effect of Ezetimibe on Serum Remnant-Like Particle (RLP) Cholesterol in dyslipidemic patients with Diabetes Mellitus or the Metabolic Syndrome (EZREC Study)

Effect of Ezetimibe on Serum Remnant-Like Particle (RLP) Cholesterol in dyslipidemic patients with Diabetes Mellitus or the Metabolic Syndrome (EZREC Study) - Effect of Ezetimibe on RLP- Cholesterol in dyslipidemic patients with DM or MetS (EZREC Study)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002202

Enrollment

170

Registered

2009-08-01

Start date

2009-09-01

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

Hypercholesterolemia, Dyslipidemia

Interventions

Ezetimibe (10mg) daily, for 12 weeks Diet therapy, for 12 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who meet all of the following criteria: 1. Patients with DM or MetS 2. Patients with not reaching target LDL-cholesterol (Japan Atherosclerosis Society Guideline 2007). 3. Over 20 years 4. Patients who provided written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients who had ischemic heart diseases 2. Patients who had stroke within the past 12 weeks 3. TG => 400 mg/dL 4. Familial Hypercholesterolemia 5. Patients with insulin treatment 6. Serious liver or renal diseases 7. Serious pulmonary disorder, and uncontrollable heart failure or arrhythmia 8. Patients who had taken probcol within the past 8 weeks 9. Patients who had been prescribed any other anti-hypercholesterol drugs within the past 4 weeks 10. Secondary dyslipidemia and drug induced dyslipidemia 11. Alcoholism, drug abuse or severe mental disorders 12. Patients who had severe anaphylactic reaction to ezetimibe or any other drug 13. During pregnancy or lactation 14. Other conditions precluding participation as judged by the investigator

Design outcomes

Primary

Measure	Time frame
Percent change of the serum levels of RLP- Cholesterol	—

Secondary

Measure	Time frame
Percent change of the serum levels of following parameters: total cholesterol (T-C), triglyceride, HDL-C, LDL-C, non-HDL-C, Apolipoproteins (A-I, A-II, B, C-II, C-III, E), ApoB/ApoA-I, small dense LDL, total adiponectin, high-sensitivity CRP, oxidized LDL, soluble LOX-1, Lp-PLA2, homocystein 2) Adverse Events	—

Countries

Japan

Contacts

Public ContactManabu MINAMI, MD, PhD

Kyoto University Hospital Translational Research Center

mminami@kuhp.kyoto-u.ac.jp075-751-4739

Outcome results

None listed

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