Optimal combination of pharmacological agents for cardiovascular and renal complications of diabetes mellitus and impaired glucose tolerance

UMIN ID: UMIN000000901

Registered date:01/04/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Cardiovascular and renal complications of diabetes mellitus and impaired glucose tolerance
• Date of first enrollment: 2005/10/01
• Target sample size: 300
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

A water soluble statin (Pravastatin) for hyperlipidemia and antihypertensive agents except angiotensin receptor blockers (ARBs) and angiotensin converting enzyme inhibitors (ACEIs) such as Calcium (Ca) antagonists for hypertension for a year.
A water soluble statin (Pravastatin) for hyperlipidemia and an ARB (Losartan) for hypertension for a year.
A lipid soluble statin (Atorvastatin) for hyperlipidemia and antihypertensive agents except ARBs and ACEIs such as Ca antagonists for hypertension for a year.
A lipid soluble statin (Atorvastatin) for hyperlipidemia and an ARB (Losartan) for hypertension for a year.

Outcome(s)

• Primary Outcome: Impaired glucose tolerance, Insulin resistance; HOMA-R, Initial renal disease; Urinalysis for protein, Vascular disease; pulse wave velocity (PWV)
• Secondary Outcome: Blood pressure at rest, Pulse rate, Total cholesterol, Triglyceride, HDL cholesterol, Fasting plasma glucose (FPG), Hemoglobin A1c (HbA1c), Fasting serum insulin, Height, Weight, Body mass index(BMI), Echocardiography (IVSt, PWt, LVEDd, LVESd, Diastolic function; E/A ratio, Deceleration time), Electrocardiography at rest, Serum Creatinine, Urinalysis, Urine Creatinine, Urine Albumin, Intima-media thickness and plaque by carotid echography, Ankle-Brachial index(ABI), Total death count, Incidence of cardiovascular event, Incidence of discontinuance, Incidence of advers event

Key inclusion & exclusion criteria

• Age minimum: 30years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1) Receiving insulin therapy 2) Having severe liver dysfunction or cirrhosis 3) Having severe renal dysfunction (Cre>=2.0) or under hemodialysis 4) Cerebrovascular disease within 3 months 5) Unstable angina, acute myocardial infarction, or severe coronary artery disease (left main trunk or 3-vessel disease) 6) Left ventricular dysfunction (LVEF<35%) 7) Not controlled hypertension (systolic BP>=180 mmHg with antihypertensive agents) 8) Not controlled hyperlipidemia (serum LDL level 180>=mmHg with antihyperlipidemic agents) 9) Having malignant tumor 10) Taking a steroid 11) Having allergy against these drugs 12) During pregnancy or the lactation period or having wish for pregnancy within a year 13) Regarded as unsuitable by the doctor in charge

Related Information

• Primary Sponsor: Kyoto Medical Centar
• Source(s) of Monetary Support: Japanese Government