Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2026-02-26 @ 5:46 PM
Study NCT ID:
NCT03945435
Status:
COMPLETED
Last Update Posted:
2019-08-19
First Post:
2018-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanisms of Exercise Resistance in Metabolic Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018149', 'term': 'Glucose Intolerance'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum Skeletal Muscle'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-15', 'studyFirstSubmitDate': '2018-05-23', 'studyFirstSubmitQcDate': '2019-05-08', 'lastUpdatePostDateStruct': {'date': '2019-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VO2peak', 'timeFrame': 'One week', 'description': 'Cardiorespiratory Fitness'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise', 'Cardiorespiratory Fitness', 'Skeletal Muscle', 'Angiogenesis'], 'conditions': ['Impaired Glucose Tolerance']}, 'descriptionModule': {'briefSummary': 'This project will determine exercise capacity and molecular markers of the response to acute exercise in human subjects with impaired or normal glucose tolerance.', 'detailedDescription': 'Low exercise capacity is an early clinical marker of metabolic impairment that predicts type 2 diabetes (T2D) risk, as well as future co-morbidities and complications. Aerobic exercise training is the only effective treatment to increase exercise capacity and reduce metabolic risk. However, despite maintaining similar levels of physical activity, exercise capacity remains lower in people with impaired glucose tolerance and T2D, compared to those with normal glucose tolerance, suggesting "exercise resistance". The mechanisms of exercise resistance in metabolic disease are unknown. In preclinical studies, exercise-induced increases in circulating angiogenic markers and skeletal muscle capillary density predict improved exercise capacity with training. Furthermore, it was demonstrated that impaired glucose tolerance precedes exercise resistance and impaired exercise-induce angiogenesis in muscle. Based on these data, it was hypothesized that exercise resistance in human T2D is caused by an impaired angiogenic response to exercise, secondary to impaired glycemic control. This study will determine whether the angiogenic response to a single bout of exercise in human subjects is blunted in patients with impaired glucose tolerance (IGT), compared to those with normal glucose tolerance (NGT). Angiogenic potential will be measured using a novel in vitro assay developed to assess endothelial tube-formation induced by circulating serum angiogenic regulators following exercise. In addition, a novel exercise-activated signaling pathway in skeletal muscle that is predictive of exercise resistance in animal models was identified. A second aim of the proposed investigation is to determine the effect of impaired glucose tolerance on molecular signaling in response to exercise in skeletal muscle. This investigation represents a critical step in determining the mechanisms that contribute to low exercise capacity in individuals at risk for diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study population will be men and women from the Boston area', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-45, BMI 26-32 kg/m2, Sedentary Lifestyle\n\nExclusion Criteria:\n\n* Type 1 or Type 2 diabetes, heart or lung disease, hypertension, contraindications to exercise testing, pregnancy'}, 'identificationModule': {'nctId': 'NCT03945435', 'briefTitle': 'Mechanisms of Exercise Resistance in Metabolic Disease', 'organization': {'class': 'OTHER', 'fullName': 'Joslin Diabetes Center'}, 'officialTitle': 'Mechanisms of Exercise Resistance in Metabolic Disease', 'orgStudyIdInfo': {'id': '2017-09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal Glucose Tolerance', 'description': 'Blood glucose level of less than 140 mg/dL at the 2 hour timepoint.'}, {'label': 'Impaired Glucose Tolerance', 'description': 'Blood glucose level of greater or equal to 140 mg/dL at the 2 hour timepoint.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Joslin Diabetes Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Sarah Lessard, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Joslin Diabetes Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Joslin Diabetes Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}