Effect of ezetimibe/statin combination therapy in patients with type 2 diabetes and dyslipidemia on remnant and inflammation

UMIN ID: UMIN000002318

Registered date:11/08/2009

Basic Information

• Health condition(s) or Problem(s) studied: type 2 diabetes with hypercholesterolemia
• Date of first enrollment: 2009/08/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Ezetimibe (10mg) daily, for 4 months

Outcome(s)

• Primary Outcome: Change of the serum levels of RLP- Cholesterol (4 months after initiaion of therapy)
• Secondary Outcome: Change of the serum levels of the following serum inflammatory markers and lipids(4 months after initiaion of therapy) 1)hsCRP, 2)IL-6, 3)IL-18, 4)apoB48, 5)total cholesterol, 6)LDL cholesterol, 7)HDL cholesterol, 8)triglyceride, 9)adiponectin, 10)TNFa, 11)insulin

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1)During pregnancy or lactation 2)Patients who had allergy to ezetimibe 3)Serious liver or renal diseases 4)Acute or chronic inflammatory diseases 5)Other conditions precluding participation as judged by the investigator

Related Information

• Primary Sponsor: Kobe University Graduate School of Medicine, Division of Diabetes, Metabolism and Endocrinology
• Secondary Sponsor: Rokko Island Hspital, Konan Hospital, Shin-Suma Hospital, Obara Hospital, Sugano Clinic, Ooshiro Clinic, Amano Clinic, Osaka Koseinenkin Hospital
• Source(s) of Monetary Support: Kobe University Graduate School of Medicine, Division of Diabetes, Metabolism and Endocrinology