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临床试验/NCT01007227
NCT01007227已完成不适用

Achievement of Dietetic and Exercise Therapy Evaluated by Self-assessment Score Significantly Improved Endothelial Dysfunction in Patients With Metabolic Syndrome

Kumamoto University2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2006年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
Endothelial function assessed by RH-PAT

研究概览

简要总结

Life-style intervention with dietetic and exercise therapy is an important fundamental approach to patients with metabolic syndrome (MetSyd) which may cause endothelial dysfunction leading to cardiovascular events. We investigated whether the life-style modification by dietetic and exercise instruction could improve endothelial dysfunction assessed by a new non-invasive and automatic device; digital reactive hyperemia peripheral arterial tonometry (RH-PAT).

详细描述

Outline of methods RH-PAT was measured in high-risk patients under 70 years old. The MetSyd was defined according to guidelines of the National Cholesterol Education Program Third Adult Treatment Panel (NCEP - ATP III). We instructed all MetSyd patients about the dietetic and exercise therapy according to the Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases. we conducted a questionnaire survey of the self-assessment for dietetic and exercise instruction program, respectively.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Under 70 years old and preserved left ventricular systolic function (left ventricular ejection fraction ≥ 50%)

排除标准

  • Severe valvular heart disease
  • Atrial septal defect
  • Myocarditis
  • Cardiomyopathy
  • Active inflammatory diseases
  • Pulmonary hypertension
  • Chronic kidney disease on hemodialysis
  • Advanced hepatic disease
  • Schizophrenia; AND
  • Cerebrovascular disease and residual hemiplegia.

研究组 & 干预措施

Lifestyle instruction

Other

干预措施: Lifestyle instruction (Other)

结局指标

主要结局

Endothelial function assessed by RH-PAT

时间窗: About 1 year later

次要结局

  • Metabolic status including waist circumference(About 1 year later)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Seigo Sugiyama

MD, PhD

Kumamoto University

研究点 (2)

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