Effects of Normobaric Hypoxia and Different Exercise Modes on Blood Glucose Regulation in Overweight Adults

November 20, 2023 updated by: Swinburne University of Technology

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 low-oxygen availability (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.

However, findings from studies investigating the potential for hypoxia to augment the exercise training response and subsequent metabolic health are equivocal. Notably, there is a lack of information regarding the optimal combination of exercise variables and hypoxic severity 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 different exercise modes under moderate hypoxia (FiO2, 16.5%).

The investigators hypothesize that all exercises combined with hypoxia improve glucose homeostasis in overweight individuals.

Study Overview

Detailed Description

In the present randomized, single-blind, cross-over study, participants will be exposed to moderate hypoxia (oxygen level 16.5%) during three different exercises (low-intensity cycling, sprint interval and functional exercises). Participants will be randomly assigned to each exercise 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 are required to attend the laboratory 8 times. These visits are including pre-exercise screening, baseline blood sampling, body composition screening and exercise in altitude conditions.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kuala Lumpur, Malaysia, 57000
        • National Sports Institute of Malaysia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • BMI is between 25-29 kg/m²
  • Physical inactive (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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Moderate hypoxia
The participant will perform different exercise modes under moderate hypoxia (fraction oxygen: 16.5%). Blood samples immediately after exercise oral glucose tolerance test will be collected.
The participants will perform low-intensity cycling exercise at 90% lactate threshold under moderate hypoxia
The participants will perform sprint interval cycling exercise at a load of 7.5% bodyweight under moderate hypoxia.
The participants will perform bodyweight exercises under moderate hypoxia.
Other: Control normoxia
The participant will not perform any exercise under normoxia and moderate hypoxia. Blood samples of oral glucose tolerance test will be collected.
No exercise will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral glucose tolerance test (glucose)
Time Frame: Change of fasting and postprandial plasma glucose concentrations compared to different exercise mode at immediately after exercise
Change of plasma glucose concentration immediately post-exercise under different exercise modes
Change of fasting and postprandial plasma glucose concentrations compared to different exercise mode at immediately after exercise
Oral glucose tolerance test (insulin)
Time Frame: Change of fasting and postprandial plasma insulin concentrations compared to different exercise mode at immediately after exercise
Change of plasma insulin concentration immediately post-exercise under different exercise modes
Change of fasting and postprandial plasma insulin concentrations compared to different exercise mode at immediately after exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2023

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

November 13, 2022

First Submitted That Met QC Criteria

November 21, 2022

First Posted (Actual)

November 28, 2022

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • ISNRP-003-2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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