Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-28 @ 5:18 AM
Study NCT ID:
NCT01962857
Status:
SUSPENDED
Last Update Posted:
2016-06-03
First Post:
2013-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of 4 Weeks of Shuttle Run Training on Insulin Sensitivity in Sedentary Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'whyStopped': 'No member of staff available for active recruitment at the moment', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-02', 'studyFirstSubmitDate': '2013-10-08', 'studyFirstSubmitQcDate': '2013-10-10', 'lastUpdatePostDateStruct': {'date': '2016-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Objectively measured physical activity', 'timeFrame': 'Change from baseline to week 4 of intervention', 'description': 'Time spent sedentary and physically active assessed by accelerometer'}], 'primaryOutcomes': [{'measure': 'Insulin sensitivity', 'timeFrame': 'Change from baseline immediately post-intervention (4 weeks after baseline)', 'description': 'Assessed from glucose and insulin concentrations in fasted state and during oral glucose tolerance test.'}], 'secondaryOutcomes': [{'measure': 'Resting substrate utilization', 'timeFrame': 'Change from baseline immediately post-intervention (4 weeks after baseline)', 'description': 'Metabolic rate and fat and carbohydrate oxidation estimated via indirect calorimetry'}, {'measure': 'Endurance exercise performance', 'timeFrame': 'Change from baseline immediately post-intervention (4 weeks after baseline)', 'description': 'Time taken to complete 100 x 10m shuttle runs'}, {'measure': 'Sprint exercise performance', 'timeFrame': 'Change from baseline immediately post-intervention (4 weeks after baseline)', 'description': 'Time taken to complete 10 x 10m shuttle runs'}, {'measure': 'Body weight', 'timeFrame': 'Change from baseline immediately post-intervention (4 weeks after baseline)'}, {'measure': 'Waist circumference', 'timeFrame': 'Change from baseline immediately post-intervention (4 weeks after baseline)'}, {'measure': 'Percentage body fat', 'timeFrame': 'Change from baseline immediately post-intervention (4 weeks after baseline)'}, {'measure': 'Clustered Cardiometabolic Risk Score', 'timeFrame': 'Change from baseline immediately post-intervention (4 weeks after baseline)', 'description': 'Clustered Cardiometabolic Risk Score = -zHDL+zInsulin+zGlucose+zTriglycerides+( zBMI+zWC)/2+(zSBP+zDBP)/2.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Physical activity', 'Exercise', 'Insulin resistance', 'High intensity interval training', 'Fat oxidation', 'Fitness', 'Lipids', 'Blood pressure'], 'conditions': ['Insulin Resistance', 'Obesity', 'Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'A number of studies have shown that short duration, high intensity interval training can improve health-related outcomes, such as insulin sensitivity and cardiorespiratory fitness. However, these often use specialized equipment, such as cycle ergometers, which makes it difficult to roll these interventions out for wide-scale use in the general population. This study aims evaluate the effects of a high intensity shuttle running intervention on insulin sensitivity, fitness and related cardiometabolic risk factors in men who are currently inactive. Participants will be randomized into intervention (4 weeks of shuttle running) and control groups. We hypothesize that the shuttle running programme will result in improved insulin sensitivity, fitness and increased fat oxidation at rest compared with the control group.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male\n* 18-40 years\n* undertaking \\< 1 hour per week of planned exercise\n\nExclusion Criteria:\n\n* BMI \\> 35 kg/m2\n* Blood pressure \\> 160/90 mm Hg (on anti-hypertensive medication)\n* history of established coronary heart disease\n* family history of early cardiac death (\\<40 years)'}, 'identificationModule': {'nctId': 'NCT01962857', 'briefTitle': 'Effect of 4 Weeks of Shuttle Run Training on Insulin Sensitivity in Sedentary Men', 'organization': {'class': 'OTHER', 'fullName': 'University of Glasgow'}, 'officialTitle': 'Effect of 4 Weeks of Shuttle Run Training on Insulin Sensitivity in Sedentary Men', 'orgStudyIdInfo': {'id': 'FBLS1020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise', 'description': '4 week supervised high-intensity shuttle running intervention, with 3 sessions per week (12 sessions in total)', 'interventionNames': ['Behavioral: Exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No intervention - participants maintain usual lifestyle'}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': '4-week supervised high intensity shuttle running intervention, 3 sessions per week (12 sessions in total)', 'armGroupLabels': ['Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G12 8QQ', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'University of Glasgow', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'overallOfficials': [{'name': 'Jason Gill, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Glasgow'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Glasgow', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Reader in Exercise Metabolism', 'investigatorFullName': 'Dr Jason Gill', 'investigatorAffiliation': 'University of Glasgow'}}}}