Cardiovascular and renal complications of diabetes mellitus and impaired glucose tolerance
Conditions
Interventions
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
Sponsors
Kyoto Medical Centar
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Positive findings from all of the following tests: 1) Positive findings from one of a)-d) a) Impaired glucose tolerance; FPG from 110 to <126 mg/dl or 2hrPPG from 140 to <200 mg/dlorb) b) HOMR-R(=FPG x Insulin level/405) >=1.73 c) HbA1c> 5.6 d) already taking any oral hypoglycemic drugs 2) B.P. at sitting position >=130/80 mmHg 3) LDL cholesterol level >=120 mg/dl 4) At least 3 months after the first instruction of diet therapy by a specialist 5) Not taking either statins or angiotensin receptor blocker for more than 3 momnths 6) Not applying to exceptions as below
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Impaired glucose tolerance, Insulin resistance; HOMA-R, Initial renal disease; Urinalysis for protein, Vascular disease; pulse wave velocity (PWV) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactHiromichi Wada
Kyoto Medical Centar Division of Translational Resaerch
Outcome results
None listed