Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT05889767
Status:
UNKNOWN
Last Update Posted:
2023-06-05
First Post:
2023-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exercise-Induced Gut Permeability in Normal-weight Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005080', 'term': 'Exercise Test'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D016552', 'term': 'Ergometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Three study groups (n=10/ group):\n\n1. Normal weight and low body fat percent (BMI 18.5-24.9 kg/m2, body fat percent \\< 25% in males or \\< 35% in females),\n2. Normal-weight obesity (BMI 18.5-24.9 kg/m2, body fat percent \\> 25% in males or \\> 35% in female)\n3. Overt obesity and high body fat percent (BMI \\> 30 kg/m2, body fat percent \\> 25% in males or \\> 35% in females)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-02', 'studyFirstSubmitDate': '2023-05-04', 'studyFirstSubmitQcDate': '2023-06-02', 'lastUpdatePostDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Body fat percent assessment with dual-energy X-ray absorptiometry (DXA).', 'timeFrame': 'Approximately 8 months', 'description': 'The investigators will perform DXA scans on all participants to assess body fat percent.'}, {'measure': 'Absolute body fat assessment with dual-energy X-ray absorptiometry (DXA)', 'timeFrame': 'Approximately 8 months', 'description': 'The investigators will perform DXA scans on all participants to assess absolute body fat in kilograms.'}, {'measure': 'Lean mass percent assessment with dual-energy X-ray absorptiometry (DXA)', 'timeFrame': 'Approximately 8 months', 'description': 'The investigators will perform DXA scans on all participants to assess lean mass percent.'}, {'measure': 'Absolute lean mass assessment with dual-energy X-ray absorptiometry (DXA)', 'timeFrame': 'Approximately 8 months', 'description': 'The investigators will perform DXA scans on all participants to assess absolute lean mass in kilograms.'}, {'measure': 'Absolute visceral fat mass assessment with dual-energy X-ray absorptiometry (DXA)', 'timeFrame': 'Approximately 8 months', 'description': 'The investigators will perform DXA scans on all participants to assess absolute visceral mass in grams.'}, {'measure': 'Lipid panel with Abbott Piccolo Xpress Clinical Chemistry Analyzer', 'timeFrame': 'Approximately 8 months', 'description': 'The investigators will perform a lipid panel on all participants.'}], 'primaryOutcomes': [{'measure': 'Serum concentrations of FABP2 following short, intense exercise', 'timeFrame': 'Approximately 8 months', 'description': 'The investigators will examine peak and absolute change in this indicator of gut permeability after the VO2 max test on a cycle ergometer.'}, {'measure': 'Serum concentrations of LBP following short, intense exercise', 'timeFrame': 'Approximately 8 months', 'description': 'The investigators will examine peak and absolute change in this indicator of gut permeability after the VO2 max test on a cycle ergometer.'}, {'measure': 'Serum concentrations of sCD14 following short, intense exercise', 'timeFrame': 'Approximately 8 months', 'description': 'The investigators will examine peak and absolute change in this indicator of gut permeability after the VO2 max test on a cycle ergometer.'}, {'measure': 'Serum concentrations of FABP2 following sustained, moderate exercise', 'timeFrame': 'Approximately 8 months', 'description': 'The investigators will examine peak and absolute change in this indicator of gut permeability after 45-minutes of exercise at 65% VO2 max on a cycle ergometer.'}, {'measure': 'Serum concentrations of IL-6 following sustained, moderate exercise', 'timeFrame': 'Approximately 8 months', 'description': 'The investigators will examine peak and absolute change in this inflammatory marker after 45-minutes of exercise at 65% VO2 max on a cycle ergometer.'}], 'secondaryOutcomes': [{'measure': 'VO2 Max', 'timeFrame': 'Approximately 8 months', 'description': 'The investigators will compare VO2 max after the short, intense exercise session across study groups.'}, {'measure': 'Respiratory exchange ratio (RER) during VO2 max test', 'timeFrame': 'Approximately 8 months', 'description': 'The investigators will compare RER dynamics during the short, intense exercise session across study groups.'}, {'measure': 'Maximum workload during exercise sessions', 'timeFrame': 'Approximately 8 months', 'description': 'The investigators will compare workload dynamics in watts during the short, intense and moderate, sustained exercise session across study groups.'}, {'measure': 'Heart rate dynamics during exercise sessions', 'timeFrame': 'Approximately 8 months', 'description': 'The investigators will compare heart rate dynamics during the short, intense and moderate, sustained exercise session across study groups.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Normal-weight Obesity', 'Obesity']}, 'descriptionModule': {'briefSummary': 'Exercise acutely increases gut permeability and inflammation, even in healthy populations. However, whether this response differs in groups at-risk for CVD that present with low-grade inflammation (e.g., normal-weight obesity) has yet to be examined. The investigators aim to measure serum indicators of gut permeability in those with normal-weight obesity pre- and post-short, intense exercise and sustained, moderate exercise', 'detailedDescription': "The investigator's overall goal is to examine how indicators of gut permeability change in response to exercise in individuals with normal-weight obesity (i.e., normal body mass index \\[BMI\\] and high body fat percent) relative to those with a normal BMI and low body fat percent and those with a BMI in the obesity range and high body fat percent.\n\nThe investigators will examine indicators of gut permeability (specified in primary outcomes) in response to a short, intense bout of exercise (i.e., VO2 max test on a cycle ergometer) and sustained, moderate bout of exercise (i.e., 45 minutes at 65% measured VO2 max on a cycle ergometer).\n\nAdditionally, the investigators will measure basic anthropometrics, blood lipids and glucose, and body composition with DXA."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nControl group: normal BMI, body fat percentage \\< 25% (male) or \\< 35% (female)\n\nNormal-weight obesity: normal BMI, body fat percentage \\> 25% (male) or \\> 35% (female)\n\nOvert obesity: BMI in obesity range, body fat percentage \\> 25% (male) or \\> 35% (female)\n\nExclusion Criteria:\n\n* Presence of pacemaker\n* Pregnant\n* Postmenopausal status\n* History of chronically using of tobacco products, illicit drugs, anti-inflammatory drugs (e.g., NSAIDs), lipid lowering drugs\n* Recent use of antibiotics (\\< 6 weeks) and NSAIDs (\\< 3 days)\n* Established cardiometabolic disease (e.g., cardiovascular disease, type 2 diabetes) diseases inflammatory in nature (e.g., rheumatoid arthritis, inflammatory bowel disease), and/or diagnosed irritable bowel syndrome.'}, 'identificationModule': {'nctId': 'NCT05889767', 'briefTitle': 'Exercise-Induced Gut Permeability in Normal-weight Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Oklahoma State University'}, 'officialTitle': 'Indicators of Gut Permeability in Normal-weight Obesity in Response to Brief, Maximal and Sustained, Submaximal Exercise', 'orgStudyIdInfo': {'id': 'IRB-22-28-STW'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Normal weight and low body fat percent', 'description': 'The low risk comparator group for this study will consist of individuals with normal BMI (18.5 - 24.9 kg/m2) and body fat percent \\< 25% (male) or \\< 35% (female).', 'interventionNames': ['Other: Exercise tests (VO2 max test and 45-minute exercise session at 65% VO2 max)']}, {'type': 'EXPERIMENTAL', 'label': 'Normal-weight obesity', 'description': 'Individuals with normal-weight obesity will be defined as having normal BMI (18.5 - 24.9 kg/m2), body fat percent \\> 25% (male) or \\> 35% (female).', 'interventionNames': ['Other: Exercise tests (VO2 max test and 45-minute exercise session at 65% VO2 max)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Overt obesity and high body fat percent', 'description': 'Overt obesity (BMI \\> 30 kg/m2) with high body fat percent (\\> 25% \\[male\\] or \\> 35% \\[female\\]) will be used as a high-risk comparator group.', 'interventionNames': ['Other: Exercise tests (VO2 max test and 45-minute exercise session at 65% VO2 max)']}], 'interventions': [{'name': 'Exercise tests (VO2 max test and 45-minute exercise session at 65% VO2 max)', 'type': 'OTHER', 'description': 'All participants will complete two exercise sessions:\n\n1. VO2 max test on a cycle ergometer\n2. Moderate exercise session (45 minutes at 65% measured VO2 max)', 'armGroupLabels': ['Normal weight and low body fat percent', 'Normal-weight obesity', 'Overt obesity and high body fat percent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74078', 'city': 'Stillwater', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bryant H Keirns, MS', 'role': 'CONTACT', 'email': 'bryant.keirns@okstate.edu', 'phone': '316-689-1711'}], 'facility': '208 Nancy Randolph Davis, Oklahoma State University', 'geoPoint': {'lat': 36.11561, 'lon': -97.05837}}], 'centralContacts': [{'name': 'Bryant H Keirns, MS', 'role': 'CONTACT', 'email': 'bryant.keirns@okstate.edu', 'phone': '3166891711'}, {'name': 'Sam R Emerson, PhD', 'role': 'CONTACT', 'email': 'sam.emerson@okstate.edu', 'phone': '405-744-2303'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oklahoma State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Nutritional Sciences', 'investigatorFullName': 'Sam Emerson', 'investigatorAffiliation': 'Oklahoma State University'}}}}