Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-03-04 @ 10:50 PM
Study NCT ID:
NCT01732705
Status:
COMPLETED
Last Update Posted:
2021-02-09
First Post:
2012-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Intensity Interval Training (HIT) in Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072696', 'term': 'High-Intensity Interval Training'}], 'ancestors': [{'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-08', 'studyFirstSubmitDate': '2012-10-12', 'studyFirstSubmitQcDate': '2012-11-23', 'lastUpdatePostDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Glycogen content in skeletal muscle', 'timeFrame': '17 days. Before and after training session day 1, 7 and 15. Before and immediately after isoglycemic, hyperinsulinemic clamp day 17.', 'description': 'Analysis of glycogen content from muscle biopsies taken during the training period.'}], 'primaryOutcomes': [{'measure': 'Insulin sensitivity', 'timeFrame': '2 days after last training session (day 17)', 'description': 'Insulin sensitivity in trained and non-trained muscle will be measured by euglycemic hyperinsulinemic clamp method and a-v catheterization of both legs.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 2 diabetes', 'Insulin sensitivity', 'High intensity interval training'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '30585698', 'type': 'DERIVED', 'citation': 'Dela F, Ingersen A, Andersen NB, Nielsen MB, Petersen HHH, Hansen CN, Larsen S, Wojtaszewski J, Helge JW. Effects of one-legged high-intensity interval training on insulin-mediated skeletal muscle glucose homeostasis in patients with type 2 diabetes. Acta Physiol (Oxf). 2019 Jun;226(2):e13245. doi: 10.1111/apha.13245. Epub 2019 Feb 14.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of High Intensity Interval Training (HIT) on insulin sensitivity in skeletal muscle in patients with type 2 diabetes.', 'detailedDescription': 'Physical exercise increases insulin sensitivity in skeletal muscle in healthy as well as in individuals with type 2 diabetes, but implies a considerable time commitment. High intensity interval training (HIT) is time-efficient exercise consisting of repeated bouts of short duration high intensive workloads. The aim of this study is to determine the effect of HIT in patients with type 2 diabetes, and to clarify the mechanisms of a possible positive effect of HIT.\n\nExercise is performed as 2 weeks one-legged training on an ergometer bicycle. Thus one leg serves as a control leg. Insulin sensitivity in trained and non-trained muscle will be measured after completion of the overall training program by euglycemic hyperinsulinemic clamp method and a-v catheterization of both legs. Muscle biopsies will be obtained during training period for measuring of muscle glycogen content, and muscle biopsies for further analysis obtained during the experimental day.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 10 subjects with Type 2 diabetes. 10 healthy control subjects.\n* BMI 28-35\n* diet or tablet treatment for diabetes\n\nExclusion Criteria:\n\n* regular physical activity\n* diseases other than type 2 diabetes\n* insulin treatment'}, 'identificationModule': {'nctId': 'NCT01732705', 'acronym': 'HIT_T2DM', 'briefTitle': 'High Intensity Interval Training (HIT) in Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Effect of High Intensity Interval Training (HIT) on Insulin Sensitivity in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'HIT-T2DM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HIT (trained leg) DM', 'description': 'High intensity interval training for one leg (trained leg) (randomized) in patient with type 2 diabetes', 'interventionNames': ['Behavioral: High intensity interval training']}, {'type': 'NO_INTERVENTION', 'label': 'Control leg, DM', 'description': 'Control leg (untrained leg)in patient with type 2 diabetes'}, {'type': 'EXPERIMENTAL', 'label': 'HIT (trained leg), Control subject', 'description': 'High intensity interval training for one leg (trained leg) (randomized) in control subject', 'interventionNames': ['Behavioral: High intensity interval training']}, {'type': 'NO_INTERVENTION', 'label': 'Control leg, Control subject', 'description': 'Control leg (untrained leg)in control subject'}], 'interventions': [{'name': 'High intensity interval training', 'type': 'BEHAVIORAL', 'otherNames': ['High intense interval training', 'HIT', 'HIIT'], 'description': 'HIT will be conducted as 2 weeks of one legged high intense interval training (8 sessions every 2nd day). Each training session will consist of 10 x 1 min intervals on ergometer bicycle interspersed with 1 min recovery.', 'armGroupLabels': ['HIT (trained leg) DM', 'HIT (trained leg), Control subject']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2200', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Xlab, Department of Biomedical Sciences, University of Copenhagen', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Flemming Dela, MD. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xlab, Department of Biomedical Sciences, University of Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Ministry of Science, Technology and Innovation, Denmark', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, MD.', 'investigatorFullName': 'Flemming Dela', 'investigatorAffiliation': 'University of Copenhagen'}}}}