National Sports Institute of Malaysia
Kuala Lumpur, 57000, Malaysia
NCT Number: NCT05577429
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.
Looking for future studies?
Notify Me20 year–40 year
Male
Interventional
Not applicable
Kuala Lumpur, 57000, Malaysia
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.
Visit 3:
Baseline oral glucose tolerance test (OGTT)-Participants will be consumed 75 grams of glucose dissolved in water (Glucolin glucose powder) and blood samples will be collected to determine baseline glucose and insulin level.
Visit 4:
Attachment of Continuous Glucose Monitor (CGM) (FreeStyle Libre, Abbott Diabetes Care, Witney, UK) will be placed on the back of the upper arm as recommended by the manufacturer.
Visit 5:
Pre-exercise blood sampling-to determine plasma glucose, insulin and circulatory factors.
Participants will be 60 minutes of cycling bouts at 90% of LT under simulated altitude exposure (normoxia or two hypoxic conditions) in the environmental chamber.
Post-exercise blood sampling-2 hours OGTT will be performed immediately following each experimental trial to determine glucose homeostasis and circulatory factors.
Visit 6:
Post-exercise 24 hours blood sampling-to determine glucose homeostasis and circulatory factors.
Removal of CGM
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The participant will perform the exercise interventions consisting of cycling at the 90% lactate threshold at normoxia (fraction oxygen: 20.9%) for 60 minutes on separate days (5-7 days). Immediately after exercise oral glucose tolerance test (OGTT) and 24-hour glucose concentration will be monitored continuously. Pre, post and post-24 h circulatory markers will be determined.
The participant will perform the exercise interventions consisting of cycling at the 90% lactate threshold at normoxia (fraction oxygen: 16.5%) for 60 minutes on separate days (5-7 days). Immediately after exercise oral glucose tolerance test (OGTT) and 24-hour glucose concentration will be monitored continuously. Pre, post and post-24 h circulatory markers will be determined.
The participant will perform the exercise interventions consisting of cycling at the 90% lactate threshold at normoxia (fraction oxygen: 14.8%) for 60 minutes on separate days (5-7 days). Immediately after exercise oral glucose tolerance test (OGTT) and 24-hour glucose concentration will be monitored continuously. Pre, post and post-24 h circulatory markers will be determined.
Time frame: 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.
Time frame: 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.
Time frame: Change of average glucose concentration compared to moderate intensity exercise under normoxia (20.9% oxygen) up to 24 hour after exercise.
Glucose concentration will be measured in the interstitial fluid of the subcutaneous adipose tissue every 15 min using a glucose sensor (FreeStyle Libre, Abbott Diabetes Care, Witney, UK), which will be inserted subcutaneously, under skin on the arm, and will be connected to a continuous glucose monitor (Abbott FreeStyle Libre™). The cumulative effects of the acute single-bout exercise will be determined using the average 24 hours glucose levels collected on post 24 h.
Time frame: 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.
Moderate intensity exercise under moderate-high hypoxia compared to normoxia. Pre, immediate post and post 24 hours blood will be sampled and analysed for circulating markers by means of ELISA
Time frame: Change of concentrations of apelin compared to moderate intensity exercise under normoxia (20.9% oxygen)immediately after exercise and at 24 hours after exercise.
Moderate intensity exercise under moderate-high hypoxia compared to normoxia. Pre, immediate post and post 24 hours blood will be sampled and analysed for circulating markers by means of ELISA
Swinburne University of Technology
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03946241
Behavior, Body Weight
Odense, Denmark
View Trial DetailsNCT05627804
Behavior, Body Weight
Kuala Lumpur, Malaysia
View Trial DetailsNCT05056376
Behavior, Body Weight
Baltimore, Maryland, United States
View Trial DetailsNCT05981508
Behavior, Behavior, Animal
Chapel Hill, North Carolina, United States
View Trial Details