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临床试验/NCT00179023
NCT00179023已完成1 期

The Autonomic Nervous System and Obesity

Vanderbilt University1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2003年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
128
试验地点
1
主要终点
Change in supine systolic blood pressure after achieving complete ganglionic blockade.

研究概览

简要总结

In its simplest terms, obesity is the results of a positive balance between food intake and energy expenditure (EE). I.e., we take in more energy, in the form of food, than we expend, e.g., by exercise. In our sedentary society, resting EE accounts for most of total energy expenditure. The sympathetic nervous system (SNS, the one that produces adrenaline) is thought to contribute to resting EE. This conclusion is based on experiments where resting EE is decreased by beta-blockers, high blood pressure medicines that block only one aspect of the sympathetic nervous system. The investigators propose to use a different approach, by using a medication called trimethaphan that produces transient withdrawal of the autonomic nervous system. The investigators will then compare the measured resting EE before and after SNS withdraw and quantify the degree of contribution to the resting EE by the SNS and delineate differences between healthy normal, healthy obese, and patients with autonomic dysfunctions.

详细描述

The rationale for this study is that even small alterations to energy metabolism can significantly change energy balance and body weight in the long term. We will test the hypothesis that the sympathetic nervous system (SNS) activity contributes to resting and thermogenic components of energy expenditure (EE).

This study is divided in four different parts: (1), (2), (3), (4).

Part (1): we will gauge the contribution of the sympathetic nervous system to resting energy expenditure, blood pressure, and determine differences between lean, obese, and patients with primary autonomic failure .

Part (2): we will determine the degree of sympathetic blockade by a gradual infusion of the ganglionic blocker trimethaphan.[Part 2 has been closed]

Part (3): we will determine the energy balance in patients with primary autonomic failure.

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
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy normal (BMI <= 25 Kg/m2), obese (BMI between 30 and 40)volunteers, lean hypertensive (BMI 20-28 Kg/m2), and obese hypertensive (BMI between 30 and 40)
  • Ages 18-60
  • Patients with pure autonomic failure and multiple system atrophy ages 18-80, referred to our service for the diagnosis and treatment of their condition, and their age sex-matched sedentary, healthy controls ages 18-80
  • Exclusion criteria:
  • All medical students
  • Pregnant women
  • Heart failure, symptomatic coronary artery disease, liver impairment, history of stroke or myocardial infarction, glaucoma
  • History of serious allergies or asthma
  • Subjects using beta-blockers

排除标准

  • 未提供

研究组 & 干预措施

Part 1

Other

Estimation of resting energy expenditure and effect of autonomic blockade with trimethaphan infusion.

干预措施: Trimethaphan (Drug)

Part 2 (closed)

Other

Estimation of autonomic function and effect of autonomic blockade with trimethaphan infusion.

干预措施: Trimethaphan (Drug)

Part 3

Other

Estimation of energy metabolism and effect of sympathetic stimulation with pseudoephedrine.

干预措施: Pseudoephedrine (Drug)

Part 4a (closed)

Other

Isoproterenol sensitivity in adipose and muscle tissue with and without systemic autonomic blockade with trimethaphan infusion.

干预措施: Trimethaphan (Drug)

Part 4b (closed)

Other

Metabolic and hemodynamic response to submaximal exercise in adipose and muscle tissue with and without systemic autonomic blockade with trimethaphan infusion.

干预措施: Trimethaphan (Drug)

结局指标

主要结局

Change in supine systolic blood pressure after achieving complete ganglionic blockade.

时间窗: 1-2 hour

次要结局

  • Change in resting energy expenditure after achieving complete autonomic blockade.(1-2 hour)

研究者

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

Italo Biaggioni

Professor of Medicine and Pharmacology

Vanderbilt University Medical Center

研究点 (1)

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