A 36 Week Three-Center Double-Blind Randomized Cross-Over Trial Comparing Metabolic Effects of Candesartan, Hydrochlorothiazide and Placebo
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Compare the effect of candesartan and hydorclorothiszide treatment on insulin sensitivity assessed with hyperinsulinemic euglycemic clamp
研究概览
简要总结
The purpose of this study is to investigate the effect of a 12-week candesartan treatment compared with hydrochlorothiazide on insulin sensitivity assessed with hyperinsulinemic euglycemic clamp.
详细描述
To investigate the mechanisms underlaying the diabetes-preventing effect of candesartan with respect to possible impact on insulin sensitivity, beta cell function and adipose tissue function and distribution. For this purpose comparisons will be performed with hydrochlorothiazide and placebo treatment. It is hypothesized that candesartan will improve insulin sensitivity as compared to hydrochlorothiazide and possibly also in comparison with placebo and that this could be explained by altered fat tissue function or distribution or by an altered sympathetic to parasympathetic balance in the autonomic nervous system. Hydrochlorthiazide is chosen as comparator because thiazides are a recommended firs-line therapy in hypertension. This drug class has some detrimental effects on glucose tolerance and in insulin sensitivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female 18-70 years old
- •Diagnosed hypertension and abdominal obesity (waist circumference greater than or equal to 102 cm (M) or 88 cm (F)
排除标准
- •Uncontrolled hypertension
- •Treatment with more than two concomitant antihypertensive medications
- •Diabetes Mellitus
- •Other endocrine disorder
- •Severe liver disease
- •Severely reduced renal function
- •Malignant disease
- •Alcohol or drug abuse
- •Severe psychiatric illness
- •History of stroke, myocardial infarction, unstable angina pectoris, participation in another clinical trial less than two months prior to screening visit
- •treatment with anti-obesity drugs
- •anti-inflammatory drugs or immunosuppressive drugs
研究组 & 干预措施
1
Candesartan 16-32 mg once daily
干预措施: Candesartan (Drug)
2
Hydrochlorothiazide 25-50 mg once daily
干预措施: Hydrochlorothiazide (Drug)
3
干预措施: Placebo (Drug)
结局指标
主要结局
Compare the effect of candesartan and hydorclorothiszide treatment on insulin sensitivity assessed with hyperinsulinemic euglycemic clamp
时间窗: 12 weeks
次要结局
- Compare the effect of candesartan treatment with placebo on insulin sensitivity and compared with hydrochlorothiazide and placebo on:(12 weeks)
- beta cell function(12 weeks)
- vascular/endothelial function;(12 weeks)
- lipolysis regulation(12 weeks)
- autonomic nerve activity;(12 weeks)
- abdominal fat tissue distribution;(12 weeks)
- amount of lean body and fat mass;(12 weeks)
- liver and muscle fat;(12 weeks)
- interaction betw. insulin and AT-II in fat cell metabolism; fat cell gene expression(12 weeks)
- adipokine levels(12 weeks)