OverweightNCT05627804
Effects of Normobaric Hypoxia and Different Exercise Modes on Blood Glucose Regulation in Overweight Adults
A study testing Low-moderate intensity exercise, Sprint interval training and Functional exercise in people with Overweight and Healthy, run by Swinburne University of Technology at 1 site in Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight, Healthy, Physical Inactivity
- What is being tested?
- Low-moderate intensity exercise, Sprint interval training and Functional exercise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteMalaysia
- Study dates
- 3 Jan 2023to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Impaired glucose tolerance (2 hour glucose: >7.8 - 11.1 mmol/L)
- Type 2 diabetes mellitus
- Obstructive sleep apnea
- Chronic obstructive pulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Overweight, Healthy, Physical Inactivity
- Being tested
- Low-moderate intensity exercise, Sprint interval training, Functional exercise, Control
- Medical subject headings
- Overweight, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-moderate intensity exerciseOther
The participants will perform low-intensity cycling exercise at 90% lactate threshold under moderate hypoxia
Sprint interval trainingOther
The participants will perform sprint interval cycling exercise at a load of 7.5% bodyweight under moderate hypoxia.
Functional exerciseOther
The participants will perform bodyweight exercises under moderate hypoxia.
ControlOther
No exercise will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Moderate hypoxia | Experimental | 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. Receives: Other: Low-moderate intensity exercise; Other: Sprint interval training; Other: Functional exercise |
| Control normoxia | Other | The participant will not perform any exercise under normoxia and moderate hypoxia. Blood samples of oral glucose tolerance test will be collected. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral glucose tolerance test (glucose)
Change of plasma glucose concentration immediately post-exercise under different exercise modes
Measured: Change of fasting and postprandial plasma glucose concentrations compared to different exercise mode at immediately after exercise
Oral glucose tolerance test (insulin)
Change of plasma insulin concentration immediately post-exercise under different exercise modes
Measured: Change of fasting and postprandial plasma insulin concentrations compared to different exercise mode at immediately after exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start3 Jan 2023
- Primary completion30 Jun 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swinburne University of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- National Sports Institute of Malaysia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627804
- Sponsor's protocol ID
- ISNRP-003-2020
- Status last verified
- Nov 2023
- First submitted
- 13 Nov 2022
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Normobaric Hypoxia and Different Exercise Modes on Blood Glucose Regulation in Overweight Adults
- ClinicalTrials.gov ID
- NCT05627804
- Acronym / sponsor ID
- ISNRP-003-2020
- Conditions
- Overweight, Healthy, Physical Inactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Swinburne University of TechnologyUniversity, hospital or other
- Collaborators
- National Sports Institute of Malaysia
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 28 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate hypoxia | Experimental | Other: Low-moderate intensity exercise, Other: Sprint interval training, Other: Functional exerciseThe 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. |
| Control normoxia | Other | Other: ControlThe participant will not perform any exercise under normoxia and moderate hypoxia. Blood samples of oral glucose tolerance test will be collected. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Impaired glucose tolerance (2 hour glucose: >7.8 - 11.1 mmol/L)
- Type 2 diabetes mellitus
- Obstructive sleep apnea
- Chronic obstructive pulmonary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-moderate intensity exerciseThe participants will perform low-intensity cycling exercise at 90% lactate threshold under moderate hypoxia | Other | Moderate hypoxia |
| Sprint interval trainingThe participants will perform sprint interval cycling exercise at a load of 7.5% bodyweight under moderate hypoxia. | Other | Moderate hypoxia |
| Functional exerciseThe participants will perform bodyweight exercises under moderate hypoxia. | Other | Moderate hypoxia |
| ControlNo exercise will be performed. | Other | Control normoxia |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-moderate intensity exercise, Sprint interval training and Functional exercise in people with Overweight and Healthy, run by Swinburne University of Technology at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral glucose tolerance test (glucose) (time frame: Change of fasting and postprandial plasma glucose concentrations compared to different exercise mode at immediately after exercise). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.