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临床试验/NCT00538486
NCT00538486已完成4 期

Which is the Best Treatment for Non-diabetic Hypertension With Obesity: Telmisartan, Amlodipine or Candesartan, Alone or Plus MEtformin? (HOT-ACME 1)

Third Military Medical University1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2008年2月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Telmisartan

干预措施: Telmisartan (Drug)

Group T+M

Experimental

Telmisartan plus Metformin

干预措施: Telmisartan plus Metformin (Drug)

Group C

Experimental

Candesartan

干预措施: Candesartan (Drug)

Group C+M

Experimental

Candesartan pus Metformin

干预措施: Candesartan plus Metformin (Drug)

Group A

Active Comparator

Amlodipine

干预措施: Amlodipine (Drug)

Group A+M

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhiming Zhu

Director of Dept. of Hypertension & Endocrinology

Third Military Medical University

研究点 (1)

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