Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-01-09 @ 2:11 AM
Study NCT ID:
NCT04450134
Status:
COMPLETED
Last Update Posted:
2024-06-07
First Post:
2020-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Histamine H1/H2 Receptors and Training Adaptations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007785', 'term': 'Lactose'}, {'id': 'C093230', 'term': 'fexofenadine'}, {'id': 'D015738', 'term': 'Famotidine'}, {'id': 'D000072696', 'term': 'High-Intensity Interval Training'}], 'ancestors': [{'id': 'D004187', 'term': 'Disaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-blind for researchers and participants'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Placebo + exercise vs histamine blockade + exercise'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-05', 'studyFirstSubmitDate': '2020-06-09', 'studyFirstSubmitQcDate': '2020-06-25', 'lastUpdatePostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in cardiorespiratory fitness', 'timeFrame': 'Before, after 3 weeks and after 6 weeks of exercise training', 'description': 'Change in maximal oxygen uptake during incremental cycling test on cycle ergometer during the 6 week training period'}, {'measure': 'Change in peak aerobic power output', 'timeFrame': 'Before, after 3 weeks and after 6 weeks of exercise training', 'description': 'Change in peak power output during incremental cycling test on cycle ergometer during the 6 week training period'}, {'measure': 'Change in whole-body insulin sensitivity', 'timeFrame': 'Before and after 6 weeks of exercise training', 'description': 'Change from baseline in Matsuda index for whole-body insulin sensitivity derived from Oral Glucose Tolerance Test after the 6 week training period'}, {'measure': 'Change in microvascular function', 'timeFrame': 'Before and after 6 weeks of exercise training', 'description': 'Change from baseline in microvascular function (Single Passive Leg Movement technique) after the 6 week training period'}], 'secondaryOutcomes': [{'measure': 'Change in skeletal muscle capillarization', 'timeFrame': 'Before and after 6 weeks of exercise training', 'description': 'Change from baseline in skeletal muscle capillarization (immunohistochemistry) after the 6 week training period'}, {'measure': 'Change in skeletal muscle enzyme activity', 'timeFrame': 'Before and after 6 weeks of exercise training', 'description': 'Change from baseline in enzyme activity assessment of markers of relevance for skeletal muscle function after the 6 week training period'}, {'measure': 'Change in skeletal muscle protein content', 'timeFrame': 'Before and after 6 weeks of exercise training', 'description': 'Change from baseline in Western Blot assessment of markers of relevance for skeletal muscle function after the 6 week training period'}, {'measure': 'Change in power output at Gas Exchange Threshold (GET)', 'timeFrame': 'Before, after 3 weeks and after 6 weeks of exercise training', 'description': 'Change from baseline in GET during incremental cycling test after the 6 week training period'}, {'measure': 'Change in power output at Respiratory Compensation Point (RCP)', 'timeFrame': 'Before, after 3 weeks and after 6 weeks of exercise training', 'description': 'Change from baseline in RCP during incremental cycling test after the 6 week training period'}, {'measure': 'Change in time to exhaustion performance test', 'timeFrame': 'Before, after 3 weeks and after 6 weeks of exercise training', 'description': 'Change in time to exhaustion test (performed after incremental cycling test) during the 6 week training period'}, {'measure': 'Change in heart rate during submaximal cycling', 'timeFrame': 'Before and after 6 weeks of exercise training', 'description': 'Change from baseline in heart rate during submaximal cycling after the 6 week training period'}, {'measure': 'Change in substrate oxidation during submaximal cycling', 'timeFrame': 'Before and after 6 weeks of exercise training', 'description': 'Change from baseline in substrate oxidation during submaximal cycling test (estimated via gas exchange data) after the 6 week training period'}, {'measure': 'Change in blood lactate accumulation during submaximal cycling', 'timeFrame': 'Before and after 6 weeks of exercise training', 'description': 'Change from baseline in capillary lactate concentration at end of submaximal cycling test after the 6 week training period'}, {'measure': 'Change in cycling efficiency during submaximal cycling', 'timeFrame': 'Before and after 6 weeks of exercise training', 'description': 'Change from baseline in cycling efficiency (estimated via gas exchange data) after the 6 week training period'}, {'measure': 'Change in fasted serum insulin concentrations', 'timeFrame': 'Before and after 6 weeks of exercise training', 'description': 'Change from baseline in fasted blood concentrations of insulin after the 6 week training period'}, {'measure': 'Change in fasted serum glucose concentrations', 'timeFrame': 'Before and after 6 weeks of exercise training', 'description': 'Change from baseline in fasted blood concentrations of glucose after the 6 week training period'}, {'measure': 'Change in fasted serum cholesterol concentrations', 'timeFrame': 'Before and after 6 weeks of exercise training', 'description': 'Change from baseline in fasted blood concentrations of cholesterol after the 6 week training period'}, {'measure': 'Change in fasted serum triglyceride concentrations', 'timeFrame': 'Before and after 6 weeks of exercise training', 'description': 'Change from baseline in fasted blood concentrations of triglyceride after the 6 week training period'}, {'measure': 'Change in resting blood pressure', 'timeFrame': 'Before and after 6 weeks of exercise training', 'description': 'Change from baseline in resting mean arterial blood pressure after the 6 week training period'}, {'measure': 'Change in resting heart rate', 'timeFrame': 'Before and after 6 weeks of exercise training', 'description': 'Change from baseline in resting heart rate after the 6 week training period'}, {'measure': 'Change in body weight', 'timeFrame': 'Before and after 6 weeks of exercise training', 'description': 'Change from baseline in total body weight after the 6 week training period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise', 'Physiology'], 'conditions': ['Exercise Training', 'Physical Activity']}, 'descriptionModule': {'briefSummary': 'Exercise training is beneficial for both health and performance. Histamine has been shown to be involved in the acute exercise response. The current study addresses the role of histamine H1/H2 receptor signaling in the chronic training-induced adaptations. Results from this study will yield more insights into the molecular mechanisms of adaptations to exercise training.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sedentary or low levels of physical activity\n* Caucasian\n\nExclusion Criteria:\n\n* Chronic diseases\n* Medication use\n* Smoking\n* Excessive alcohol consumption\n* Seasonal allergies'}, 'identificationModule': {'nctId': 'NCT04450134', 'briefTitle': 'Histamine H1/H2 Receptors and Training Adaptations', 'organization': {'class': 'OTHER', 'fullName': 'University Ghent'}, 'officialTitle': 'Role of Histamine H1/H2 Receptors in the Health- and Performance-promoting Adaptations to High-intensity Interval Training', 'orgStudyIdInfo': {'id': 'HIST-TRAINING (BC-06009)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '6 weeks high-intensity interval training + placebo intake', 'interventionNames': ['Other: Lactose', 'Other: High-intensity interval training (HIIT)']}, {'type': 'EXPERIMENTAL', 'label': 'Blockade', 'description': '6 weeks high-intensity interval training + histamine H1/H2 receptor blockade', 'interventionNames': ['Drug: Fexofenadine Hydrochloride', 'Drug: Famotidine', 'Other: High-intensity interval training (HIIT)']}], 'interventions': [{'name': 'Lactose', 'type': 'OTHER', 'description': 'Placebo: Lactose capsules', 'armGroupLabels': ['Placebo']}, {'name': 'Fexofenadine Hydrochloride', 'type': 'DRUG', 'description': 'H1 receptor antagonist: 540 mg Fexofenadine Hydrochloride', 'armGroupLabels': ['Blockade']}, {'name': 'Famotidine', 'type': 'DRUG', 'description': 'H2 receptor antagonist: 40 mg Famotidine', 'armGroupLabels': ['Blockade']}, {'name': 'High-intensity interval training (HIIT)', 'type': 'OTHER', 'description': '6 weeks HIIT', 'armGroupLabels': ['Blockade', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'state': 'Oost-Vlaanderen', 'country': 'Belgium', 'facility': 'Department of Movement and Sports Sciences, Ghent University', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'Research Foundation Flanders', 'class': 'OTHER'}, {'name': 'University of Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}