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临床试验/NCT00847262
NCT00847262已完成4 期

Hypertension With Obesity Trial: Diabetes Mellitus Branch

Third Military Medical University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2008年6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
120
试验地点
1
主要终点
Blood Pressure

研究概览

简要总结

Recent studies have shown that obese people are more prone to high blood pressure. With the co-existence of obesity, hypertension and diabetes, patients were more susceptible to hyperlipidemia, coronary and cerebral atherosclerosis and peripheral vascular disease. Abdominal obesity has often accompanied by substantial accumulation of visceral fat, which increased secretion of many inflammatory mediators, cytokines and adipocytokines and played an important role in cardiovascular and metabolic disease. Some reports had shown that angiotensin II receptor blockers (ARB) may improve metabolic profiles in patients with diabetes or metabolic syndrome, in addition to its hypotensive effect. It has been reported that some ARB, such as telmisartan and candesartan, can prevent weight gain and high-fat-induced obesity in experimental animals. However, whether telmisartan intervention on improvement of fat deposition and other related metabolic profiles is better than a CCB drugs (amlodipine) in those obese hypertensive patients with diabetes, was still unknown.

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
None

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

  • Information Consent Signed
  • Aged 30~70 years
  • For whom without anti-hypertensive therapy in 2 weeks:140mmHg≤SBP<180mmHg,或 90mmHg≤DBP<110mmHg. For whom with anti-hypertensive therapies in 2 weeks:SBP<180mmHg, 且 DBP<110mmHg
  • Waist circumference higher than 90cm in men, 80cm in women
  • Diagnosed diabetes

排除标准

  • Grade 3 hypertension: SBP≥180mmHg, or DBP≥110mmHg
  • Waist circumference less than 90cm in men, 80cm in women
  • Known allergy or hypersensitivity to trial drugs
  • NYHA grade Ⅱ~Ⅳ heart failure, Myocardial infarction or cerebrovascular accident in 1 year preceding the trial
  • Acute infections, tumor, severe arrhythmia, mental disease, drug or alcohol abuse
  • History of hepatitis or cirrhosis
  • History of severe kidney disease
  • Pregnant, lactation
  • Enrolled in other trials in 3 months
  • Any obstacles of follow-up or compliance

研究组 & 干预措施

Telmisartan Group

Experimental

Telmisartan intervention group

干预措施: Temisartan (Drug)

Amlodipine Group

Active Comparator

Amlodipine intervention group

干预措施: Amlodipine (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))
  • Incidents of side effects between groups(Baseline, 24 weeks(End of trial))
  • Obesity parameters, including waist circumference (WC) and body mass index (BMI)(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

Chief of the Department of Hypertension & Endocrinology

Third Military Medical University

研究点 (1)

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