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临床试验/NCT03921853
NCT03921853已完成不适用

Preventing Metabolic Syndrome in Patients With Morbid Obesity by Resistance Training: Reporting Non-responder Prevalence

Universidad de Los Lagos2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2018年1月1日最近更新:
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
39
试验地点
2
主要终点
Fasting glucose

研究概览

简要总结

The researchers will conduct a study for avoiding the metabolic syndrome in morbid obese patients. Thus, the aim of the present will be determine the effects of a resistance training programme (RT) in preventing or attenuating metabolic syndrome (MetS) in patients with morbid obesity. A second aim will be report the prevalence of non-responders in terms of improvements in MetS markers and other co-variables considered.

详细描述

The prevalence of metabolic syndrome (MetS) and cardiovascular disease is expected to rise along with the global obesity epidemic. MetS is a cluster of clinical risk factors, including abdominal (visceral) obesity, hypertension, elevated serum triglycerides, low serum high-density lipoprotein (HDL) and hyperglycaemia.The MetS for example, significantly decreases the life expectancy of individuals with morbid obesity and increases the disease burden and economic costs associated with healthcare. In this sense, more recently, there was reported that body mass index (BMI) and fat distribution showed higher associations with inflammation, fat indices, and more prevalence of MetS in morbidly obese subjects, claiming for an early prevention of the MetS in the morbid obese state.

Exercise training has proven to be effective in inducing a clinically significant weight loss and reducing cardiovascular risk. Exercise have reported to be associated with increased muscle mass, decreased body fat, and improved metabolic profile (i.e., improved glucose control and lipid levels). In addition, supervised RT improved muscle strength and functional capacity in patients with obesity undergoing bariatric surgery. However, although RT has been widely studied in obesity, there is little information in the morbid obesity. On the other hand, there is poor knowledge similarly, about the interindividual variability to exercise training in terms of responders and non-responders (NR). Thus, considering the poor knowledge about the MetS prevention in morbid obese patients, as well as the little information about Responders and Non-Responders for improving MetS outcomes, the aim of this study will be determine the effects of a RT program on cardio-metabolic outcomes of MetS in patients with morbid obesity. A second aim will be report the prevalence of non-responders in terms of the effects of resistance training on MetS markers and other health-related variables.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

盲法说明

According with the availability and the feasibility of the enrolment's requirements, patients will be allocated to a control group with obesity, and another with morbid obesity.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Inclusion Criteria:
  • Older than 18 and younger and ≤65 years of age.
  • With risk factors to Metabolic syndrome
  • With obesity and morbid obesity condition
  • Medical authorization by a physician.

排除标准

  • Physical limitations (e.g., restricting injuries of the musculoskeletal system, or dependent of a third person).
  • Exercise-related dyspnoea or respiratory alterations.
  • Chronic heart disease with any worsening in the last month.
  • Adherence rate of less than 80% of the total interventions.

研究组 & 干预措施

Active comparator

Active Comparator

Control group with obesity under Resistant Training

干预措施: Behavioral (Other)

Experimental group with morbid obesity

Experimental

Experimental group with morbid obesity under Resistant Training

干预措施: Behavioral (Other)

结局指标

主要结局

Fasting glucose

时间窗: Change from Baseline Fasting glucose at 20-weeks of Resistant Training

Component of the Metabolic Syndrome

High density lipoprotein

时间窗: Change from Baseline High density lipoprotein at 20-weeks of Resistant Training

Component of the Metabolic Syndrome

Systolic blood pressure and diastolic blood pressure

时间窗: from Baseline Systolic blood pressure and diastolic blood after 20-weeks of Resistant Training

Component of the Metabolic Syndrome

Waist circumference

时间窗: Change from Baseline Waist circumference at 20-weeks of Resistant Training

Component of the Metabolic Syndrome

Triglycerides

时间窗: Change from Baseline Triglycerides at 20-weeks of Resistant Training

Component of the Metabolic Syndrome

次要结局

  • Body mass index(Change from Baseline Body mass index at 20-weeks of Resistant Training)
  • Body mass(Change from Baseline Body mass at 20-weeks of Resistant Training)
  • Total cholesterol(Change from Baseline Total cholesterol at 20-weeks of Resistant Training)
  • Low density lipoprotein(Change from Baseline Low density lipoprotein at 20-weeks of Resistant Training)
  • Six minutes walking test(Change from Baseline Six minutes walking test density lipoprotein at 20-weeks of Resistant Training)
  • One maximum repetition of biceps curl(Change from Baseline One maximum repetition of biceps curl at 20-weeks of Resistant Training)
  • Handgrip muscle strength(Change from Baseline Handgrip muscle strength at 20-weeks of Resistant Training)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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