A 26-week, Single Center, Randomized, Placebo-controlled, Double-blind, Parallel-group Study to Evaluate the Effect of Rosuvastatin on Visceral Adipose Tissue in Male Patients With Abdominal Obesity
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change in Visceral Adipose Tissue Area Measured by Computed Tomography.
研究概览
简要总结
The purpose of this study is to investigate whether 6 months treatment with the cholesterol-lowering drug rosuvastatin may reduce visceral fat tissue in obese middle aged men.
详细描述
The accumulation of intra-abdominal fat has been suggested to be of primary importance in the development of the metabolic syndrome and associated metabolic disturbances and it has been hypothesized that a selective reduction of visceral fat tissue would improve the symptoms of the metabolic syndrome. Treatment with statins decrease levels of LDL-cholesterol and reduce coronary artery disease (CAD) events. Although it is widely accepted that the majority of benefit obtained with statins is a direct result of their lipid-lowering properties, they also demonstrate additional cholesterol-independent or pleiotropic effects. The results of experimental studies have now shown that statins decrease fat mass in the visceral region in an animal model. In the present study, we will investigate whether statins can decrease visceral obesity in humans.
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients between 40 and 65 years of age.
- •Abdominal obesity
- •Dyslipidemia
- •Written informed consent.
排除标准
- •Uncontrolled hypertension
- •Diabetes mellitus
- •Severe liver disease
- •Severely reduced renal function
- •Uncontrolled endocrine disorders
- •History of or ongoing malignant disease
- •Patients with known myopathic disease
- •Recent alcohol or drug abuse
- •Weight loss or weight gain during the three months prior to screening.
- •Ongoing treatment with statins
- •Ongoing treatment with calcineurin-inhibitors
- •Ongoing treatment with anti-inflammatory drugs
- •Received an investigational drug within 30 days prior to screening.
- •Strong clinical indication for statin treatment
- •In the Principal Investigator's opinion, the patient has other clinically significant cardiac, oncologic, neurologic or psychiatric disease that could be adversely affected by Study participation.
- •For any reason the patient is considered by the Principal Investigator to be an unsuitable candidate to participate in the Study.
研究组 & 干预措施
Rosuvastatin
干预措施: Rosuvastatin (Drug)
Placebo for Rosuvastatin
干预措施: Placebo for rosuvastatin (Drug)
结局指标
主要结局
Change in Visceral Adipose Tissue Area Measured by Computed Tomography.
时间窗: 6 months
次要结局
- Change in Subcutaneous Adipose Tissue Area(6 months)
- Change in LDL(6 months)
- Change in Hepatic Fat Infiltration Measured by CT.(6 months)
- Change in the Ratio Between Intra-abdominal and Subcutaneous Tissue Area Measured by CT.(6 months)
- Change in Body Weight(6 months)