Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-29 @ 3:02 PM
Study NCT ID:
NCT05857150
Status:
RECRUITING
Last Update Posted:
2025-08-29
First Post:
2023-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Response in Humans With 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'}, {'id': 'D015502', 'term': 'Absorptiometry, Photon'}, {'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], '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'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D003720', 'term': 'Densitometry'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D014054', 'term': 'Tomography'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Sample of DNA stored for possible future research use at Mayo Clinic.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2029-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-22', 'studyFirstSubmitDate': '2023-05-04', 'studyFirstSubmitQcDate': '2023-05-04', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in muscle protein synthesis', 'timeFrame': 'Baseline, post-exercise approximately 8 hours', 'description': 'Skeletal muscle protein synthesis will be measured from the rate of incorporation of infused amino acids measured by mass spectrometry.'}], 'secondaryOutcomes': [{'measure': 'Change in mRNA expression of exercise responsive genes', 'timeFrame': 'Baseline, post-exercise approximately 8 hours', 'description': 'Measure messenger ribonucleic acids (mRNAs) expression on exercise responsive genes'}, {'measure': 'Change in expression and activation (phosphorylation) of signaling proteins', 'timeFrame': 'Baseline, post-exercise approximately 8 hours', 'description': 'Phosphorylation is a common mechanism for the regulation of receptor function'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obese']}, 'descriptionModule': {'briefSummary': 'This study is being done to understand how chronic inflammation affects muscle function and responses to exercise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Men and women ages 20-45 years with Body Mass Index less than 25 or greater than 30 kg/m2.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obese men and women ≥ 20 and ≤ 45 years of age.\n\nExclusion Criteria:\n\n* Diabetes or fasting plasma glucose \\>126 mg/dL\n* Anemia (female subjects hemoglobin of \\<11 g/dl and male subjects hemoglobin \\<12 g/dl)\n* Active coronary artery disease or history of unstable macrovascular disease (unstable angina, myocardial infarction, stroke, and revascularization of coronary, peripheral or carotid artery within 3 months of recruitment)\n* Renal failure (serum creatinine \\> 1.5mg/dl)\n* Chronic active liver disease defined as aspartate aminotransferase (AST)\\>144 IU/L or alanine transaminase (ALT) \\>165 IU/L)\n* Oral warfarin group medications or history of blood clotting disorders.\n* Smoking\n* Pregnancy or breastfeeding\n* Alcohol consumption greater than 2 glasses/day or other substance abuse\n* Untreated or uncontrolled hypothyroidism\n* Debilitating chronic disease (at the discretion of the investigators)'}, 'identificationModule': {'nctId': 'NCT05857150', 'briefTitle': 'Exercise Response in Humans With Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Exercise Response in Humans With Obesity', 'orgStudyIdInfo': {'id': '22-012396'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lean Group', 'description': 'Participants with body mass index 20-25 kg/m\\^2 will complete an outpatient study visit (body composition, blood draw, treadmill test, strength test) and an inpatient visit (muscle biopsies, fat biopsies, indirect calorimetry, exercise test).', 'interventionNames': ['Diagnostic Test: Treadmill Test', 'Diagnostic Test: Strength Test', 'Diagnostic Test: Dual-Energy X-Ray Absorptiometry', 'Procedure: Muscle Biopsy', 'Procedure: Fat Biopsy', 'Diagnostic Test: Resting Energy Expenditure', 'Diagnostic Test: Magnetic resonance imaging']}, {'label': 'Obese Group', 'description': 'Participants with body mass index 30-45 kg/m\\^2 will complete an outpatient study visit (body composition, blood draw, treadmill test, strength test) and an inpatient visit (muscle biopsies, fat biopsies, indirect calorimetry, exercise test).', 'interventionNames': ['Diagnostic Test: Treadmill Test', 'Diagnostic Test: Strength Test', 'Diagnostic Test: Dual-Energy X-Ray Absorptiometry', 'Procedure: Muscle Biopsy', 'Procedure: Fat Biopsy', 'Diagnostic Test: Resting Energy Expenditure', 'Diagnostic Test: Magnetic resonance imaging']}], 'interventions': [{'name': 'Treadmill Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurement of whole-body fitness level. Walking or running on a treadmill and breathing into a machine that measures oxygen level during test. Heart rhythm is continuously monitored during exercise using an electrocardiogram (ECG).', 'armGroupLabels': ['Lean Group', 'Obese Group']}, {'name': 'Strength Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measure the strength of leg muscles by kicking against a machine with resistance.', 'armGroupLabels': ['Lean Group', 'Obese Group']}, {'name': 'Dual-Energy X-Ray Absorptiometry', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['DEXA'], 'description': 'Body composition measurement.', 'armGroupLabels': ['Lean Group', 'Obese Group']}, {'name': 'Muscle Biopsy', 'type': 'PROCEDURE', 'description': 'Obtain a small piece of muscles from the upper part of the legs', 'armGroupLabels': ['Lean Group', 'Obese Group']}, {'name': 'Fat Biopsy', 'type': 'PROCEDURE', 'description': 'Fat sample taken from abdomen', 'armGroupLabels': ['Lean Group', 'Obese Group']}, {'name': 'Resting Energy Expenditure', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['REE'], 'description': 'Measured by indirect calorimetry. Measures how much energy the body uses at rest by placing a special plastic dome over the head while resting quietly for 30 minutes. Measures oxygen breathed in and carbon dioxide breathed out.', 'armGroupLabels': ['Lean Group', 'Obese Group']}, {'name': 'Magnetic resonance imaging', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['MRI'], 'description': 'MRI on upper leg to look at fat and muscle', 'armGroupLabels': ['Lean Group', 'Obese Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rachel Passehl', 'role': 'CONTACT', 'email': 'Passehl.Rachel@mayo.edu', 'phone': '507-255-8112'}], 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'Rachel Passehl', 'role': 'CONTACT', 'email': 'Passehl.Rachel@mayo.edu', 'phone': '507-255-8112'}], 'overallOfficials': [{'name': 'Ian Lanza, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ian R. Lanza', 'investigatorAffiliation': 'Mayo Clinic'}}}}