Which is the Best Treatment for Non-diabetic Hypertension With Obesity: Telmisartan, Amlodipine or Candesartan, Alone or Plus MEtformin? (HOT-ACME 1)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Blood Pressure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Grade 1 or 2 hypertension: 140mmHg≤SBP<180mmHg, and/or 90mmHg≤DBP<110mmHg
- •Waist circumference higher than 90cm in men, 80cm in women
排除标准
- •Grade 3 hypertension: SBP≥180mmHg, or DBP≥110mmHg
- •known allergy or hypersensitivity to trial drugs
- •Myocardial infarction or cerebrovascular accident in the year preceding the trial
- •Clinical Congestive Heart Failure
- •History of hepatitis or cirrhosis
- •History of kidney disease
研究组 & 干预措施
Group T
Telmisartan
干预措施: Telmisartan (Drug)
Group T+M
Telmisartan plus Metformin
干预措施: Telmisartan plus Metformin (Drug)
Group C
Candesartan
干预措施: Candesartan (Drug)
Group C+M
Candesartan pus Metformin
干预措施: Candesartan plus Metformin (Drug)
Group A
Amlodipine
干预措施: Amlodipine (Drug)
Group A+M
Amlodipine plus Metformin
干预措施: Amlodipine plus Metformin (Drug)
结局指标
主要结局
Blood Pressure
时间窗: Baseline, 24 weeks(End of trial)
Metabolic profiles, including lipid profile and blood glucose
时间窗: Baseline, 24 weeks(End of trial)
次要结局
- Abdominal fat assessed by CT(Baseline, 24 weeks(End of trial))
- Obesity parameters, including waist circumference (WC) and body mass index (BMI)(Baseline, 24 weeks(End of trial))
- Insulin resistance assessed by fasting serum insulin and HOMA-IR(Baseline, 24 weeks(End of trial))
- Incidents of side effects between groups(Baseline, 24 weeks(End of trial))
研究者
Zhiming Zhu
Director of Dept. of Hypertension & Endocrinology
Third Military Medical University
