The study for beneficial efficacy and safety of ezetimibe in patients with hyper LDL-cholesterolemia associated with diabetes mellitus (DM) including glucose intolerance and non-alcoholic fatty liver disease (NAFLD)

The study for beneficial efficacy and safety of ezetimibe in patients with hyper LDL-cholesterolemia associated with diabetes mellitus (DM) including glucose intolerance and non-alcoholic fatty liver disease (NAFLD) - The study for beneficial efficacy of ezetimibe in patients with hyper LDL-cholesterolemia with diabetes and NAFLD

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004462

Enrollment

Registered

2010-11-01

Start date

2010-03-01

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

non-alcoholic fatty liver disease, diabetes mellitus, hyper LDL-cholesterolemia

Interventions

the administration of ezetimibe, 10mg per day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The outpatients with less than 180mg/dl of LDL-cholestrol level and without achieving the management target set in Guidelines for Cardiovascular Disease Prevention 2007

Exclusion criteria

Exclusion criteria: 1) the subjects currently receiving ezetimibe 2) the subjects infected with hepatitis B or C virus 3) the subjects with more than 500mg/dl of triglyceride 4) the subjects with familial hyperlipidemia, secondary hyperlipidemia and drug induced-hyperlipidemia 5) the subjects drinking alcohol more than 21g per day frequently 6) the subjects receiving pioglitazone 7) the subjects recommended the other medication 8) the subjects with hyperlipidemia induced by: hypothyroidism, obstructive biliary tract disease, pancreatitis, cushing syndrome, lupus erythematosus, malignant lymphoma, myeloma. 9) the subjects with poor controlled diabetes (HbA1c > 9.0%) 10) the subjects having a history of a previous drug allergy 11) the subjects during pregnancy or lactation 12) the subjects found offensive by attending physicians for this research

Design outcomes

Primary

Measure	Time frame
The rate of change in LDL-cholesterol level after 24 weeks from entry	—

Secondary

Measure	Time frame
1) the rate of change of fat accumulation in liver by abdominal ultrasound 2) the rate of change of hepatic function test 3) the rate of change of glucose tolerance 4) the rate of change of serum lipid level other than LDL-cholesterol 5) the rate of change of inflammatory markers 6) the rate of change of oxidative stress markers 7) safety	—

Countries

Japan

Contacts

Public ContactKen Sugimoto

Osaka University Graduate School of Medicine Geriatric Medicine

sugimoto@geriat.med.osaka-u.ac.jp06-6879-3852

Outcome results

None listed

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