Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2025-12-24 @ 2:22 PM
Study NCT ID:
NCT06617195
Status:
RECRUITING
Last Update Posted:
2025-01-20
First Post:
2024-09-13
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mechanisms of Anabolic Resistance in Older Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma Serum Adipose tissue Skeletal muscle tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2030-09-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-17', 'studyFirstSubmitDate': '2024-09-13', 'studyFirstSubmitQcDate': '2024-09-25', 'lastUpdatePostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anabolic response', 'timeFrame': '2 months', 'description': 'Skeletal muscle protein synthesis rates will be measured from isotopic enrichment of muscle proteins'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aging']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to understand how chronic inflammation affects muscle function and responses to exercise in older adults.', 'detailedDescription': 'Inflamed adipose tissue may contribute to blunted exercise response in skeletal muscle of older adults. The objective of this project is to evaluate a hypothesis that inflamed adipose secretes factors that activate inflammatory cascades in skeletal muscle, which may interfere with exercise-responsive molecular pathways and contribute to dysfunctional muscle phenotypes with aging. This project determine how adipose tissue influences skeletal muscle function and anabolic response to exercise in older adults. Young and older adults will complete studies to assess molecular response to acute exercise from protein synthesis rates, mRNA of exercise-responsive genes, and activation of signaling proteins in skeletal muscle. Adipose tissue will be assessed using a combination of non-invasive imaging and biopsy-based molecular phenotyping. The project will determine if acute exercise response is attenuated in older adults with inflamed adipose tissue phenotype.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '21 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Men and women age 21-35 years or 70-85 years of age', 'healthyVolunteers': True, 'eligibilityCriteria': 'Exclusion Criteria:\n\n1. Diabetes or fasting plasma glucose 126 mg/dL\n2. Body mass index (BMI) 30 kg/m2\n3. Anemia (female subjects hemoglobin of \\<11 g/dl and male subjects hemoglobin \\<12 g/dl)\n4. 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)\n5. Renal failure (serum creatinine \\> 1.5mg/dl)\n6. Chronic active liver disease (AST\\>144IU/L or ALT\\>165IU/L)\n7. Oral warfarin group medications or history of blood clotting disorders.\n8. Smoking\n9. Pregnancy or breastfeeding\n10. Alcohol consumption greater than 2 glasses/day or other substance abuse\n11. Untreated or uncontrolled hypothyroidism\n12. Debilitating chronic disease (at the discretion of the investigators)'}, 'identificationModule': {'nctId': 'NCT06617195', 'briefTitle': 'Mechanisms of Anabolic Resistance in Older Humans', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Mechanisms of Anabolic Resistance in Older Humans', 'orgStudyIdInfo': {'id': '24-003329'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Young', 'description': 'Men and women between the ages of 21-35 years will be recruited for this study. All participants will complete an outpatient study day (body composition, blood draw, treadmill test, strength test) and an inpatient study day (muscle biopsies, fat biopsies, indirect calorimetry, exercise test).', 'interventionNames': ['Other: Exercise']}, {'label': 'Older', 'description': 'Men and women between the ages of 70-85 years will be recruited for this study. All participants will complete an outpatient study day (body composition, blood draw, treadmill test, strength test) and an inpatient study day (muscle biopsies, fat biopsies, indirect calorimetry, exercise test).', 'interventionNames': ['Other: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'Young and older adults will perform a single bout of unaccustomed resistance exercise to evaluate molecular and cellular response in skeletal muscle', 'armGroupLabels': ['Older', 'Young']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ian R Lanza, PhD', 'role': 'CONTACT', 'email': 'lanza.ian@mayo.edu', 'phone': '507-255-8147'}, {'name': 'Ian R Lanza, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'Rachel Passehl', 'role': 'CONTACT', 'email': 'passehl.rachel@mayo.edu', 'phone': '507-255-8112'}, {'name': 'Ian Lanza', 'role': 'CONTACT', 'email': 'lanza.ian@mayo.edu'}], 'overallOfficials': [{'name': 'Ian Lanza', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Anthropometric data Primary and secondary outcomes'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ian R. Lanza', 'investigatorAffiliation': 'Mayo Clinic'}}}}