Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2026-01-02 @ 12:02 PM
Study NCT ID:
NCT07128368
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-08-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanisms of Resistance Exercise Training for Improved Muscle Insulin Sensitivity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-08-13', 'studyFirstSubmitQcDate': '2025-08-13', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in muscle protein synthesis', 'timeFrame': 'Baseline; 8 weeks', 'description': 'Rate of insulin-stimulated synthesis of individual proteins'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Resistance Training']}, 'descriptionModule': {'briefSummary': 'To uncover the underlying mechanisms of resistance exercise training benefits on glucose metabolism and insulin sensitivity in muscle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Sedentary (≤30min of physical activity on ≤1 day/week)\n* Weight stable for ≥3 months prior to study\n\nExclusion Criteria:\n\n* Active coronary artery disease or heart failure.\n* Participation in a structured exercise program \\> 1 day/week.\n* A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:\n\n * Abnormal liver function test results (Transaminase \\>2 times the upper limit of normal)\n * Abnormal renal function test results (calculated GFR \\<60 mL/min/1.73m2); If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study\n * Uncontrolled thyroid disease (TSH undetectable or \\>10 mlU/L); testing required within three months prior to admission for subjects with a goiter, positive antibodies, or who are on thyroid hormone replacement, and within one year otherwise\n * Abuse of alcohol or recreational drugs\n * Active tobacco usage\n * Infectious process not anticipated to resolve prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis).\n * Uncontrolled arterial hypertension (Resting diastolic blood pressure \\>90 mmHg and/or systolic blood pressure \\>160 mmHg) at the time of screening.\n * A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol\n * Active pregnancy\n * Menopause (defined as absence of menstruation for 12 consecutive months)\n * Restrictions on Use of Other Drugs or Treatments:\n\n * Any other medication believed to be a contraindication to the subject's participation."}, 'identificationModule': {'nctId': 'NCT07128368', 'briefTitle': 'Mechanisms of Resistance Exercise Training for Improved Muscle Insulin Sensitivity', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Mechanisms of Resistance Exercise Training for Improved Muscle Insulin Sensitivity', 'orgStudyIdInfo': {'id': '24-011544'}, 'secondaryIdInfos': [{'id': 'K01DK141911', 'link': 'https://reporter.nih.gov/quickSearch/K01DK141911', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Resistance Exercise Training', 'interventionNames': ['Other: Resistance Exercise Training']}], 'interventions': [{'name': 'Resistance Exercise Training', 'type': 'OTHER', 'description': 'Participants will undergo resistance exercise training 3 days a week for approximately 1 hour each day for 8 weeks.', 'armGroupLabels': ['Resistance Exercise Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Mark Pataky', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Consultant I Endocrinology, Diabetes and Metabolism', 'investigatorFullName': 'Mark Pataky', 'investigatorAffiliation': 'Mayo Clinic'}}}}