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临床试验/NCT05482178
NCT05482178Unknown不适用

The Potential Role of Resistance Exercise on Inflammasome Activation and Cytokines Levels in Obese Subjects

Elisa Barron-Cabrera2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年5月31日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
2
主要终点
IL-18 cytokine

研究概览

简要总结

The intervention study consist in 3 months of follow up to evaluate the effect of resistance exercise on NLRP3 and interleukin-18 (IL-18) gene expression, and IL-18 and IL-1b cytokines levels in obese subjects, due to, the current evidence has been suggested that aerobic physical exercise could reduce the low-grade chronic inflammation through the downregulation of the NLRP3 inflammasome in obesity subjects, however, there are not enough evidence with resistance protocol. The investigator randomized into two intervention groups: a) group with resistance exercise training plus hypocaloric diet, and b) group with hypocaloric diet. The blood sample was taken fasting at baseline and final intervention (3rd month). The serum was separated for biochemical analyzes and the quantification of cytokines levels. The RNA was obtained from leukocytes to expression assay.

详细描述

Obesity is a metabolic condition with a high worldwide prevalence. It is characterized by low-grade chronic inflammation and high cytokines level as consequence of the excessive accumulation of adipose tissue. The NLRP3 protein is part of the NLRP3 inflammasome, a multiprotein complex related to inflammation and the risk of developing metabolic disorders. In this sense, the evidence has been suggested that physical exercise could reduce the inflammation through the downregulation of the NLRP3 inflammasome. The aim of this study is evaluate the effect of resistance exercise on NLRP3 and IL-18 gene expression and and IL-18 and IL-1b cytokines levels in obese subjects. This is an experimental study with 3 months of follow up. Participants were randomized into two intervention groups: a) group with resistance exercise plus hypocaloric diet, and b) group with hypocaloric diet. The exercise program was design by certified personal trained, and consisted in 3 phases: conditioning, development and maintenance. Dietary information was collect by validated retrospective questionnaires (24-hour record and 3-days dietary diary) and analyzed in Nutritionist Pro software. Body composition was evaluated by bioimpedance. The biochemical analyzes were performed on serum sample using spectrophotometry equipment. RNA was obtained from leukocytes from peripheral blood, cDNA synthesis was performed with a ThermoFisher kit, and the expression assay was performed by real-time polymerase chain reaction (PCR) using Taqman probes with the 2-ΔΔcq relative quantification method. Cytokines quantification were perform using a commercial ELISA kit. Statistical analysis will be using the Statistical Package for Social Sciences (SPSS v.25) software and a value of p<0.05 will be considered statistically significant.

研究设计

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

入排标准

年龄范围
25 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Older than 25 years old
  • Women with waist circumference ≥ 80cm and men with ≥ 90cm
  • Subjects with BMI between 30 and 40 kg/m2

排除标准

  • Subjects with diagnosis of metabolic alterations
  • Subjects with chronic pharmacological treatment
  • Subjects with anti-inflammatories drugs prescription

结局指标

主要结局

IL-18 cytokine

时间窗: Change from baseline IL-18 cytokine at 3 months

commercial ELISA kit

IL-1b cytokine

时间窗: Change from baseline IL-1b cytokine at 3 months

commercial ELISA kit

NLRP3 gene expression

时间窗: Change from baseline NLRP3 gene expression at 3 months

Assay expression will be performed by real-time PCR using Taqman probes with the 2-ΔΔcq relative quantification method

IL-18 gene expression

时间窗: Change from baseline IL-18 gene expression at 3 months

Assay expression will be performed by real-time PCR using Taqman probes with the 2-ΔΔcq relative quantification method

次要结局

  • Weight(Change from baseline weight at 3 months)
  • Serum glucose(Change from baseline serum glucose at 3 months)
  • Body fat mass(Change from baseline body fat mass at 3 months)
  • Serum triglycerides(Change from baseline serum triglycerides at 3 months)
  • Serum cholesterol(Change from baseline serum cholesterol at 3 months)

研究者

发起方
Elisa Barron-Cabrera
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Elisa Barron-Cabrera

Professor

Universidad Autónoma de Sinaloa

研究点 (2)

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