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

NCT ID: NCT05627804

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-03

Study Completion Date

2023-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Overweight Healthy Physical Inactivity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Low-moderate intensity exercise

Intervention Type OTHER

The participants will perform low-intensity cycling exercise at 90% lactate threshold under moderate hypoxia

Sprint interval training

Intervention Type OTHER

The participants will perform sprint interval cycling exercise at a load of 7.5% bodyweight under moderate hypoxia.

Functional exercise

Intervention Type OTHER

The participants will perform bodyweight exercises under moderate hypoxia.

Control normoxia

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

Group Type OTHER

Control

Intervention Type OTHER

No exercise will be performed.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Low-moderate intensity exercise

The participants will perform low-intensity cycling exercise at 90% lactate threshold under moderate hypoxia

Intervention Type OTHER

Sprint interval training

The participants will perform sprint interval cycling exercise at a load of 7.5% bodyweight under moderate hypoxia.

Intervention Type OTHER

Functional exercise

The participants will perform bodyweight exercises under moderate hypoxia.

Intervention Type OTHER

Control

No exercise will be performed.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Sports Institute of Malaysia

UNKNOWN

Sponsor Role collaborator

Swinburne University of Technology

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Sports Institute of Malaysia

Kuala Lumpur, , Malaysia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Malaysia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ISNRP-003-2020

Identifier Type: -

Identifier Source: org_study_id