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
- Interventions
- Drug: hydrochlorothiazide/telmisartanDrug: amlodipine/valsartan
- Registration Number
- NCT01819220
- Lead Sponsor
- Yonsei University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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consent to the study
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Male or Female ≥ 20 years
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Patients taking less than 1 antihypertensive medications or not taking antihypertensive medications. Hypertension defined at the screening visit as follows): 140mmHg < MSSBP or MSDBP > 90mmHg at screening
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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
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Patient not taking statin medication and if the patient had ate statin medication the last duration must be before 3 months.
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• 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 < 3.2 or > 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description hydrochlorothiazide/telmisartan hydrochlorothiazide/telmisartan - amlodipine/valsartan amlodipine/valsartan -
- Primary Outcome Measures
Name Time Method To assess the glucose change To assess the change from baseline (week 0) to study endpoint (week 24) on 2hr-post-prandial plasma glucose level using oral glucose tolerance test (75-g OGTT)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Yonsei universty medical center
🇰🇷Seoul, Korea, Republic of