Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-01-02 @ 1:06 AM
Study NCT ID:
NCT05627804
Status:
COMPLETED
Last Update Posted:
2023-11-22
First Post:
2022-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Normobaric Hypoxia and Different Exercise Modes on Blood Glucose Regulation in Overweight Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D057185', 'term': 'Sedentary Behavior'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072696', 'term': 'High-Intensity Interval Training'}], 'ancestors': [{'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2022-11-13', 'studyFirstSubmitQcDate': '2022-11-21', 'lastUpdatePostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oral glucose tolerance test (glucose)', 'timeFrame': 'Change of fasting and postprandial plasma glucose concentrations compared to different exercise mode at immediately after exercise', 'description': 'Change of plasma glucose concentration immediately post-exercise under different exercise modes'}, {'measure': 'Oral glucose tolerance test (insulin)', 'timeFrame': 'Change of fasting and postprandial plasma insulin concentrations compared to different exercise mode at immediately after exercise', 'description': 'Change of plasma insulin concentration immediately post-exercise under different exercise modes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight', 'Healthy', 'Physical Inactivity']}, 'descriptionModule': {'briefSummary': '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.\n\nHowever, 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.\n\nIn 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%).\n\nThe investigators hypothesize that all exercises combined with hypoxia improve glucose homeostasis in overweight individuals.', 'detailedDescription': '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.\n\nParticipants 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI is between 25-29 kg/m²\n* Physical inactive (physical activity \\<150 min/week)\n* No known heart or metabolic diseases (such as Type 2 diabetes)\n* Not currently taking any prescribed medication\n* No reported musculoskeletal injuries recently\n* Not exposed to hypoxia \\>1000 m prior to the study\n\nExclusion Criteria:\n\n* Impaired glucose tolerance (2 hour glucose: \\>7.8 - 11.1 mmol/L)\n* Type 2 diabetes mellitus\n* Obstructive sleep apnea\n* Chronic obstructive pulmonary disease'}, 'identificationModule': {'nctId': 'NCT05627804', 'briefTitle': 'Effects of Normobaric Hypoxia and Different Exercise Modes on Blood Glucose Regulation in Overweight Adults', 'organization': {'class': 'OTHER', 'fullName': 'Swinburne University of Technology'}, 'officialTitle': 'Effects of Normobaric Hypoxia and Different Exercise Modes on Blood Glucose Regulation in Overweight Adults', 'orgStudyIdInfo': {'id': 'ISNRP-003-2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Moderate hypoxia', '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.', 'interventionNames': ['Other: Low-moderate intensity exercise', 'Other: Sprint interval training', 'Other: Functional exercise']}, {'type': 'OTHER', 'label': 'Control normoxia', 'description': 'The participant will not perform any exercise under normoxia and moderate hypoxia. Blood samples of oral glucose tolerance test will be collected.', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Low-moderate intensity exercise', 'type': 'OTHER', 'description': 'The participants will perform low-intensity cycling exercise at 90% lactate threshold under moderate hypoxia', 'armGroupLabels': ['Moderate hypoxia']}, {'name': 'Sprint interval training', 'type': 'OTHER', 'description': 'The participants will perform sprint interval cycling exercise at a load of 7.5% bodyweight under moderate hypoxia.', 'armGroupLabels': ['Moderate hypoxia']}, {'name': 'Functional exercise', 'type': 'OTHER', 'description': 'The participants will perform bodyweight exercises under moderate hypoxia.', 'armGroupLabels': ['Moderate hypoxia']}, {'name': 'Control', 'type': 'OTHER', 'description': 'No exercise will be performed.', 'armGroupLabels': ['Control normoxia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57000', 'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'National Sports Institute of Malaysia', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swinburne University of Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Sports Institute of Malaysia', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}