Effects of Armolipid Plus on Indices of Insulin Resistance in Patients With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Rottapharm
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Insulin/glucose ratio after overnight fast
研究概览
简要总结
Metabolic syndrome is a highly prevalent condition characterized by visceral obesity, abnormalities of glucidic and lipid metabolism, and increased risk for cardiovascular events. Such findings appear to be associated with a decrease in insulin sensitivity. Management of metabolic syndrome is currently aimed at treating individual components of the disease without addressing this underlying pathophysiologic mechanism; this translates into multidrug regimens, high costs and patient compliance issues.
Armolipid Plus (an association of berberine 500 mg, red yeast rice titled in 3 mg monacolin K,policosanol 10 mg,coenzyme Q10 2 mg,astaxanthin 0,5 mg,folic acid 0,2 mg) has been found to be effective at reducing blood cholesterol and triglycerides, and at improving endothelial function; subgroup analyses also suggested a benefit on indices of insulin resistance.
Aim of the study is to evaluate the effects of Armolipid Plus on insulin sensitivity and on the diagnostic parameters of metabolic syndrome.
60 patients will be enrolled in this randomized, double-blind, placebo-controlled trial; active treatment will consist of Armolipid Plus (1 tbl qd).
Primary end point will be the reduction of the insulin/glucose ratio, both after overnight fast (HOMA index) and after an oral glucose tolerance test (OGTT).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female 18-65 aged, with diagnosis of metabolic syndrome, defined by the presence of waist circumference > 102 cm (M) or >88 cm(F), and two or more of these criteria:
- •fasting blood glucose >100 mg;
- •systolic blood pressure >135 or diastolic blood pressure >85 mmHg or patients in treatment with antihypertensive drugs;
- •triglyceridemia >150 mg/dl;
- •HDL cholesterolemia < 40 mg/dl(M), < 50 mg/dl(F).
排除标准
- •pregnancy
- •diabetes mellitus in pharmacologic treatment;
- •hepatic failure;
- •creatininemia >2 mg/dl;
- •triglyceridemia > 500 mg/dl;
- •heart failure.
结局指标
主要结局
Insulin/glucose ratio after overnight fast
时间窗: 18 weeks
HOMA INDEX
Insuline/glucose ratio after an oralglucose tolerance test
时间窗: 18 weeks
OGTT
次要结局
- BMI(18 weeks)
- Glycemia(18 weeks)
- Endothelial function(18 weeks)
- C reactive protein.(18 weeks)
- Serum lipidemia(18 weeks)