The epidemic of obesity is associated with a considerable rise in the incidence of the metabolic syndrome, type 2 diabetes mellitus, and hypertension. Insulin resistance plays an important role in the pathogenesis of obesity related hypertension. These patients are at high risk to suffer from cardiovascular events. However, current guidelines for treatment of hypertension do not provide specific recommendation for the pharmacotherapy of obese hypertensive patients due to lack of prospective randomized intervention studies in non-diabetic obese hypertensive patients. Aside from their antihypertensive effects, angiotensin II receptor blockers (ARB) were shown to improve insulin sensitivity. Furthermore, metformin is commonly used to treat the obese type 2 diabetes mellitus. Metformin can also lower body weight and increase insulin sensitivity. In a prospective, double-blind, double-dummy, randomized, parallel-group study, we will evaluate the effects of ARB (telmisartan and candesartan) or amlodipine combination with metformin on weight gain, visceral fat, and metabolic parameters in obese hypertensive patients without diabetes mellitus compared with obese hypertensives on ARB or amlodipine treatment alone. This study will help to develop future comprehensive treatment strategies and guidelines for obesity related hypertension.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
360
Telmisartan 80mg 1/d, Metformin 250mg 2/d
Telmisartan 80mg 1/d
Candesartan 8mg daily
Candesartan 8mg 1/d Metformin 250mg 2/d
Amlodipine 5mg 1/d
Amlodipine 5mg 1/d, Metformin 250mg 2/d
The third hospital affiliated to the Third Military Medical University
Chongqing, China
Blood Pressure
Time frame: Baseline, 24 weeks(End of trial)
Metabolic profiles, including lipid profile and blood glucose
Time frame: Baseline, 24 weeks(End of trial)
Abdominal fat assessed by CT
Time frame: Baseline, 24 weeks(End of trial)
Obesity parameters, including waist circumference (WC) and body mass index (BMI)
Time frame: Baseline, 24 weeks(End of trial)
Insulin resistance assessed by fasting serum insulin and HOMA-IR
Time frame: Baseline, 24 weeks(End of trial)
Incidents of side effects between groups
Time frame: Baseline, 24 weeks(End of trial)
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