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临床试验/NCT01332708
NCT01332708Unknown不适用

Cholinergic Status and the Metabolic Syndrome

Tel-Aviv Sourasky Medical Center0 个研究点目标入组 50 人开始时间: 2011年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
主要终点
total soluble circulation capacity for acetylcholine hydrolysis

研究概览

简要总结

The investigators aims in the current study are to examine whether the cholinergic status should be considered as another risk factor for the metabolic syndrome and it's co-morbidities and to test the effect of a hypocaloric high complex carbohydrates diet on the cholinergic status of overweight and obese adults with and without the metabolic syndrome.

详细描述

Intervention studies have demonstrated that the autonomic disturbances of the metabolic syndrome may be reversible. A reduction in body weight induced by a hypocaloric diet exerts a marked reduction in sympathetic activity in obese people with or without metabolic syndrome. Incorporation of regular, moderate intensity aerobic exercise training during a dietary weight loss program does not confer additional benefits on resting sympathetic neural activity, compared with weight loss by diet alone. A new method has been developed to examine the sympathetic-parasympathetic status of an individual - the cholinergic status. Cholinergic Status represents the total soluble circulation capacity for acetylcholine hydrolysis. Higher cholinergic status means the individual is more sympathetic .

A cross sectional study that took place in Tel Aviv Sorasky medical center and included 632 participants found that the cholinergic status is related to metabolic syndrome parameters in a dose response manner and that it correlates significantly with glucose,HbA1c, lipid profile and hs-CRP.

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
35 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI ≥ 25kg/m2
  • Stable weight (±1kg)in the previous six months
  • Non smokers

排除标准

  • Type II diabetes
  • Hypertension pharmacologically treated
  • Cardiovascular disease
  • Renal disease
  • Cirrhosis and end-stage liver failure
  • Thyroid disease
  • Cerebrovascular disease
  • Autoimmune disease
  • Chronic inflammatory disease
  • Surgery or heart catheterization in the previous six months
  • Use of drugs known to affect measured parameters

结局指标

主要结局

total soluble circulation capacity for acetylcholine hydrolysis

时间窗: 8 weeks or more

次要结局

  • Inflammatory markers(8 weeks or more)
  • ROTEM - rotation thromboelastometry(8 weeks or more)
  • Metabolic markers(8 weeks or more)

研究者

申办方类型
Other Gov

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Cholinergic Status and the Metabolic Syndrome | 临床试验