UMIN ID: UMIN000002261
Registered date:28/07/2009
Evaluation of combination therapy with Statin and Ezetimible for patients with type II diabetes.
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | Pateients with type II diabetes combined with dyslipidemia |
Date of first enrollment | 2009/06/01 |
Target sample size | 30 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | Ezetimibe and Statin |
Outcome(s)
Primary Outcome | Examination of the rate change of glucouse metabolism and inflammatory marker Examination of ameliorating effect in kidney function |
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Secondary Outcome | Examination of the rate change of TC, HDL cholesterol, and TG Decreasing rate of LDL cholesterol |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
Exclude criteria | 1) Pregnant and/or breathfeeding, child-bearing potential women during this study. 2) Past history of severe allergic reactions to ezetimibe 3) Renal dysfunctioned. (ALT>2 x Normal range of each institute) 4) Uncontrolled diabetes mellitus (HbA1c>=9%) 5) Renal insufficiency (serum creatinine>2.0mg/dL) 6) Heart failure, cardiac infarct, unstable angina, or stroke whithin 3 months. 7) Recieving insulin therapy 8) Secondary hyperlipidemia and/or drug-induced hyperlipidemia 9) Familial hyperlipidemia 10) otherwise, treating physician judged not to be appropriate for inclusion in this study. |
Related Information
Primary Sponsor | Department of Cardiovascular Medicine, Saga University |
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Secondary Sponsor | |
Source(s) of Monetary Support | Department of Cardiovascular Medicine, Saga University |
Secondary ID(s) |
Contact
public contact | |
Name | Koichi Node, MD, PhD |
Address | 5-1-1 Nabeshima, Saga Japan |
Telephone | 0952-34-2364 |
node@cc.saga-u.ac.jp | |
Affiliation | Saga University Department of Cardiovascular Medicine |
scientific contact | |
Name | Koichi Node, MD, PhD |
Address | 5-1-1, Nabeshima, Saga city, Saga Japan |
Telephone | 0952-34-2364 |
node@cc.saga-u.ac.jp | |
Affiliation | Saga University Department of Cardiovascular Medicine |