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

Primary Purpose

Overweight, Healthy, Physical Inactivity

Status
Not yet recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Low-moderate intensity exercise
Sprint interval training
Functional exercise
Control
Sponsored by
Swinburne University of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight

Eligibility Criteria

20 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • National Sports Institute of Malaysia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Moderate hypoxia

Control normoxia

Arm Description

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 participant will not perform any exercise under normoxia and moderate hypoxia. Blood samples of oral glucose tolerance test will be collected.

Outcomes

Primary Outcome Measures

Oral glucose tolerance test (glucose)
Change of plasma glucose concentration immediately post-exercise under different exercise modes
Oral glucose tolerance test (insulin)
Change of plasma insulin concentration immediately post-exercise under different exercise modes

Secondary Outcome Measures

Full Information

First Posted
November 13, 2022
Last Updated
November 21, 2022
Sponsor
Swinburne University of Technology
Collaborators
National Sports Institute of Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT05627804
Brief Title
Effects of Normobaric Hypoxia and Different Exercise Modes on Blood Glucose Regulation in Overweight Adults
Official Title
Effects of Normobaric Hypoxia and Different Exercise Modes on Blood Glucose Regulation in Overweight Adults
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swinburne University of Technology
Collaborators
National Sports Institute of Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Healthy, Physical Inactivity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Moderate hypoxia
Arm Type
Experimental
Arm Description
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.
Arm Title
Control normoxia
Arm Type
Other
Arm Description
The participant will not perform any exercise under normoxia and moderate hypoxia. Blood samples of oral glucose tolerance test will be collected.
Intervention Type
Other
Intervention Name(s)
Low-moderate intensity exercise
Intervention Description
The participants will perform low-intensity cycling exercise at 90% lactate threshold under moderate hypoxia
Intervention Type
Other
Intervention Name(s)
Sprint interval training
Intervention Description
The participants will perform sprint interval cycling exercise at a load of 7.5% bodyweight under moderate hypoxia.
Intervention Type
Other
Intervention Name(s)
Functional exercise
Intervention Description
The participants will perform bodyweight exercises under moderate hypoxia.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
No exercise will be performed.
Primary Outcome Measure Information:
Title
Oral glucose tolerance test (glucose)
Description
Change of plasma glucose concentration immediately post-exercise under different exercise modes
Time Frame
Change of fasting and postprandial plasma glucose concentrations compared to different exercise mode at immediately after exercise
Title
Oral glucose tolerance test (insulin)
Description
Change of plasma insulin concentration immediately post-exercise under different exercise modes
Time Frame
Change of fasting and postprandial plasma insulin concentrations compared to different exercise mode at immediately after exercise

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
National Sports Institute of Malaysia
City
Kuala Lumpur
ZIP/Postal Code
57000
Country
Malaysia

12. IPD Sharing Statement

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

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