randomized, open labeled clinical trial to compare the effectiveness of amlodipine/valsartan vs hydrochlorothiazide/telmisartan on glucose tolerance in patients with hypertension with metabolic syndrome

Conditions: Hypertension

Summary: recent studies have demonstrated that ras inhibitors/calcium channel blockers are superior to ras inhibitors/diuretics for reducing cardiovascular outcomes in hypertension. as such, ras inhibitors/calcium channel blockers are recommended as first line combination treatment for hypertension. however, the mechanism for the superior efficacy of ras inhibitors/calcium channel blockers are not well defined. this study will compare the efficacy of ras inhibitors/calcium channel blockers vs ras inhibitors/diuretics in terms of glucose tolerance and insulin resistance in hypertensive patients with metabolic syndrome. the primary endpoint will be that ras inhibitors/calcium channel blockers will be more efficacious in reducing 2hour post prandial glucose compared to ras inhibitors/diuretics.


Eligibility criteria:
inclusion criteria: * consent to the study * male or female ≥ 20 years * patients taking less than 1 antihypertensive medications or not taking antihypertensive medications. hypertension defined at the screening visit as follows): 140mmhg \ 90mmhg at screening * hypertensive patients with non diabetic metabolic syndrome will be enrolled. metabolic syndrome is defined according to ncep guideline. (3 or more than) ① abdominal obesity: waist circumference m ≥ 90cm, f ≥ 80cm ② hypertriglyceridaemia: triglycerides ≥ 150mg/dl ③ low hdl cholesterol men: hdl cholesterol ≤ 40mg/dl women: hdl cholesterol ≤ 50mg/dl ④ elevated blood pressure (systolic blood pressure ≥ 130 mmhg and diastolic blood pressure ≥ 85 mmhg, or current use of antihypertensive drugs) ⑤ impaired fasting glucose: fasting plasma glucose ≥ 100 mg/dl * patient not taking statin medication and if the patient had ate statin medication the last duration must be before 3 months. exclusion criteria: * • women of child-bearing potential without a contraceptive measure * (pregnant or nursing women * known or suspected contraindications: history of allergy or hypersensitivity * history of clinically significant allergies including asthma and/or multiple drug allergies * patients taking more than 2 antihypertensive medications * patient taking statin medication and taking statin within 3 months * mssbp \> 180 mmhg or msdbp \> 110 mmhg at any time during the study * evidence of a secondary form of hypertension) * history of hypertensive encephalopathy, cerebrovascular accident, transient ischemic attack, myocardial infarction, percutaneous coronary intervention (pci) or coronary artery bypass graft surgery (cabg) for 12 months prior to visit 1 * history of heart failure grade ii - iv according to the nyha classification * concomitant potentially life threatening arrhythmia or symptomatic arrhythmia * concomitant unstable angina pectoris * clinically significant valvular heart disease * patients with type 1 or type 2 diabetes mellitus * evidence of hepatic disease as determined by one of the following: ast or alt values ≥ 3 x unl, a history of hepatic encephalopathy, history of esophageal varices, or history of portocaval shunt * evidence of renal impairment as determined by one of the following: serum creatinine \>2mg/dl , history of dialysis, or history of nephrotic syndrome * protein in u/a values 2+ ≤ * serum potassium values \ 5.2 mmol/l * history of malignancy of any organ system within the past 5 years, treated or untreated, including leukemia and lymphoma, as further defined in the full protocol * chronic use of nsaids * use of cyclooxygenase-2 inhibitors (cox-2 inhibitors * use of niacin \> 100 mg/d * use of loop diuretics * use of statin shorter than 3 months * inability to discontinue prior antihypertensive drugs as specified in the full protocol * persons directly involved in the execution of this protocol * volume depletion based on the investigator's clinical judgment using vital signs, skin turgor, moistness of mucous membranes, and laboratory values * any severe, life-threatening disease within the past five years