跳至主要内容
临床试验/NCT03056937
NCT03056937Unknown不适用

Effects of Bariatric Surgery on Inspiratory Metaboreflex in Metabolically Healthy Obese and Obese Subjects With Metabolic Syndrome

University of Cruz Alta1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2016年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
45
试验地点
1
主要终点
Inspiratory metaboreflex

研究概览

简要总结

The hypothesis of this study is that reductions in body weight could improve inspiratory muscle function attenuating the inspiratory metaboreflex in metabolically healthy obese individuals and obese individuals with metabolic syndrome.

详细描述

Introduction

Peripheral metaboreflex activation appears to be exacerbated in obese individuals with metabolic syndrome. Interestingly, bariatric surgery attenuates the peripheral metaboreflex. Obese individuals have impaired inspiratory muscle function, which can be reversed by the reduction in body weight. Therefore, bariatric surgery could attenuate inspiratory metaboreflex in metabolically healthy obese individuals and obese individuals with metabolic syndrome. Objectives: To investigate the effects of bariatric surgery on inspiratory metaboreflex in metabolically healthy obese individuals and in obese patients with metabolic syndrome. Patients and Methods: A sample comprising of 15 obese subjects with metabolic syndrome, 15 obese subjects without metabolic syndrome and 15 healthy nonobese individuals. These subjects will be submitted to pulmonary function, respiratory muscle strength, inspiratory muscle resistance, exercise tolerance, quality of life, autonomic cardiovascular control and the inspiratory metaboreflex evaluation. The evaluations performed in obese patients with and without metabolic syndrome pre-surgery will be repeated 6 months after bariatric surgery.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Body mass index (BMI)> 35 kg / m²
  • Diagnosis of metabolic syndrome

排除标准

  • Acute health problems in the last month (viral or bacterial infections, accidents, allergic reactions)
  • Diseases of the nervous system or conditions that affect the understanding or participation in the study
  • Pregnancy
  • Type I diabetes mellitus
  • Arterial hypertension
  • Dyslipidemias
  • Coronary artery disease
  • Left ventricular dysfunction
  • Any condition interfering with locomotion
  • Bronchial asthma
  • Chronic obstructive pulmonary disease
  • Chronic neuropathies
  • Use of drugs such as corticosteroids or bronchodilators
  • Obese without Metabolic Syndrome
  • Inclusion Criteria:
  • Body mass index (BMI)> 35 kg / m²
  • Exclusion Criteria:
  • Metabolic Syndrome
  • Acute health problems in the last month (viral or bacterial infections, accidents, allergic reactions)
  • Diseases of the nervous system or conditions that affect the understanding or participation in the study
  • Pregnancy
  • Type I diabetes mellitus
  • Arterial hypertension
  • Dyslipidemias
  • Coronary artery disease
  • Left ventricular dysfunction
  • Any condition interfering with locomotion
  • Bronchial asthma
  • Chronic obstructive pulmonary disease
  • Chronic neuropathies
  • Use of drugs such as corticosteroids or bronchodilators
  • Healthy nonobese subjects
  • Inclusion Criteria:
  • BMI <25 kg / m²
  • Exclusion Criteria:
  • Non-smokers
  • Any diagnosed disease.

结局指标

主要结局

Inspiratory metaboreflex

时间窗: 6 monhs

It will be induced through a linear inspiratory resistance of 60% of maximal inspiratory pressure

次要结局

  • Inspiratory muscle resistance(6 months)
  • Autonomic cardiovascular control(6 months)
  • Exercise tolerance(6 months)
  • Quality of life(6 months)
  • Pulmonary function(6 months)
  • Respiratory muscle strength(6 months)

研究者

发起方
University of Cruz Alta
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Effects of Bariatric Surgery on Inspiratory... | 临床试验