Phase 1-2 Study of Development of Rational Ways of Medical and Non-medical Treatment Methods for Metabolic Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 351
- 试验地点
- 1
- 主要终点
- Systolic/ Diastolic Blood Pressures (mm Hg)
研究概览
简要总结
Metabolic syndrome: aetiology, pathogenesis, diagnosis, clinical management and prognosis
详细描述
Purpose: To create the complex scientifically proved concept of Metabolic syndrome (МS) development based on elaboration of the new methods of clinical diagnostics of МS components and highly effective МS clinical management in comparative studying of clinical, laboratory and cost effectiveness.
Participants and methods: This clinical study included 351 adults (184 female) in the Scientific research institute of cardiology and internal diseases (Almaty, the Republic of Kazakhstan). Statistical analysis was performed using Microsoft Excel-2008 in updating Lapach, Chubenko et al (2000) and SPSS for Windows v.17.0.
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
- 25 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •written consent form
- •age> 25 years
- •skinfold thickness > 0,7 cm BP> 130/85 mm Hg or a patient on antihypertensive medications fasting blood glucose > 6.1 mmole/L, or 2-hour postprandial glucose level > 11.1 mmole/L / or a patient with type 2 diabetes blood cholesterol > 5.6 mmole/L possibility of treatment > 6 months follow-up > 1 year
排除标准
- •complete immobilization of a patient (paresis /paralysis)
- •patients with severe concomitant diseases of the kidneys and (or) of the liver
- •early post-operative condition
- •mental illness
- •pregnancy
- •persons who are in prison
- •persons who are in military Armed Forces
研究组 & 干预措施
Conventional Patient group
Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin
干预措施: Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin (Drug)
"Analimentary detoxication" Weight loss
Vegetables and salt diet
干预措施: "Analimentary detoxication" (Dietary Supplement)
结局指标
主要结局
Systolic/ Diastolic Blood Pressures (mm Hg)
时间窗: up to 12 weeks
Systolic and Diastolic Blood Pressures (mm Hg) was measured by manual/automatic tonometery
Blood Glucose Level
时间窗: up to 12 weeks
Fasting blood glucose (FBG) (mmole/L) and Two-hour postprandial glucose (THPG) (mmole/L) were measured.
次要结局
- Immunoassay Cortisole in Blood(up to 12 weeks)
- Lipid Profile(up to 12 weeks)
- Immunoassay Hormones in Blood(up to 12 weeks)
研究者
Kuat Oshakbayev
Primary investigator
Nazarbayev University