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临床试验/NCT05577429
NCT05577429已完成不适用

The Potential of a Low Oxygen Environmental Chamber as an Aid to Exercise Training to Improve Metabolic Health

Swinburne University of Technology2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2021年6月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
2
主要终点
Fasting and postprandial plasma glucose concentration

研究概览

简要总结

Obesity is a major global health issue and a primary risk factor for metabolic-related disorders. While physical inactivity is one of the main contributors to obesity, it is a modifiable risk factor with exercise training as an established, non-pharmacological treatment to prevent the onset of metabolic-related disorders, including obesity. Exposure to hypoxia via normobaric hypoxia (simulated altitude via reduced inspired oxygen fraction), termed hypoxic conditioning, in combination with exercise has been increasingly shown in the last decade to enhance blood glucose regulation and decrease body mass index, providing a feasible strategy to treat obesity.

Nonetheless, findings from studies investigating the potential for a hypoxic environment to augment the exercise training response and subsequent metabolic health are equivocal. Notably, there is a paucity of information regarding the optimal combination of exercise variables and hypoxic load (i.e. level of hypoxia) to enable an individualized and safe practice of exercising in a hypoxic environment.

In the present randomized, single-blind, cross-over study, the investigators will investigate the effects of single-bout of exercise under normoxia (FiO2, 20.9%), moderate (FiO2, 16.5%) and high normobaric hypoxic conditions (FiO2, 14.8%) (60-min cycling session at 90% LT) on 2h OGTT and 24h-glucose level in individuals with overweight. The investigators hypothesize that exercise in combination with hypoxia improves glucose homeostasis in individuals with overweight.

详细描述

In the present randomized, single-blind, cross-over study, participants will be exposed to normobaric 1) normoxia (oxygen level 20.9%), 2) moderate hypoxia (oxygen level 16.5%) and 3) high hypoxia (oxygen level 14.8%) 1) during exercise (60 minutes on a cycle ergometer) at 90% LT. Participants will be randomly assigned to each condition (computer-generated randomization plan), separated by a washout period (5-7 days). To accomplish this, participants will exercise in an environmental chamber in which oxygen concentration of the ambient air and, as such, oxygen levels can be closely controlled and monitored. Participants will cycle for 60 minutes at a 90% lactate threshold (LT), determined by an LT test.

Visit 1 (Screening and consent):

Introduction to the research team and tour of the facility. Complete and sign the Adult Pre-Exercise Screening System form. Complete and sign the consent information form.

Visit 2:

Body composition screening using bioimpedance analysis (Inbody 770, Cerritos, CA, USA) Blood pressure screening. Lactate threshold test-participants will be riding a Velotron cycle ergometer (Racermate, Seattle, USA) with an initial load of 50 Watts. The load increased progressively in 15 Watts increments every 4 minutes, with participants maintaining a constant pedal frequency (cadence ~90 rpm) until reaching LT.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • BMI is between 25-29 kg/m²
  • Sedentary (physical activity <150 min/week)
  • No known heart or metabolic diseases (such as Type 2 diabetes)
  • Not currently taking any prescribed medication
  • No reported musculoskeletal injuries recently
  • Not exposed to hypoxia >1000 m prior to the study

排除标准

  • Impaired glucose tolerance (2 hour glucose: >7.8 - 11.1 mmol/L)
  • Type 2 diabetes mellitus
  • Obstructive sleep apnea
  • Chronic obstructive pulmonary disease

结局指标

主要结局

Fasting and postprandial plasma glucose concentration

时间窗: Change of fasting and postprandial plasma glucose concentrations (mmol/L) compared to moderate intensity exercise under normoxia (20.9% oxygen) at immediately after exercise (2 hour oral glucose tolerance test).

Change of plasma glucose concentration immediately post-exercise under hypoxia (14.8-16.5% oxygen) compared to normoxia.

Fasting and postprandial plasma insulin concentration

时间窗: Change of fasting and postprandial plasma insulin concentrations (mU/L) compared to moderate intensity exercise under normoxia (20.9% oxygen) at immediately after exercise (2 hour oral glucose tolerance test).

Change of plasma insulin concentration immediately post-exercise under hypoxia (14.8-16.5% oxygen) compared to normoxia.

次要结局

  • Average 24 hours glucose concentration(Change of average glucose concentration compared to moderate intensity exercise under normoxia (20.9% oxygen) up to 24 hour after exercise.)
  • Circulating concentration of fibroblast growth factor 21 (FGF-21)(Change of concentrations of FGF-21 compared to moderate intensity exercise under normoxia (20.9% oxygen) immediately after exercise and at 24 hours after exercise.)
  • Circulating concentration of apelin(Change of concentrations of apelin compared to moderate intensity exercise under normoxia (20.9% oxygen)immediately after exercise and at 24 hours after exercise.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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