Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2026-02-22 @ 4:53 PM
Study NCT ID:
NCT01987258
Status:
COMPLETED
Last Update Posted:
2014-02-27
First Post:
2013-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Acute Effect of Interval-walking
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}, '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': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-26', 'studyFirstSubmitDate': '2013-06-28', 'studyFirstSubmitQcDate': '2013-11-12', 'lastUpdatePostDateStruct': {'date': '2014-02-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycemic control', 'timeFrame': 'Will be assessed immediately after the intervention using a mixed meal tolerance test (duration: 5 hours) followed by continuous glucose monitoring (duration: 48 hours).', 'description': 'Glycemic control will be assessed after a one hour specific exercise intervention (control/continuous walking/interval walking) in a controlled setting (a mixed meal tolerance test). Moreover, glycemic control will be assessed during the following 2 days in a free-living environment, using continuous glucose monitoring systems.'}], 'secondaryOutcomes': [{'measure': 'Excess post-exercise oxygen consumption (EPOC)', 'timeFrame': 'Will be assessed immediately after the intervention using a ventilated hood (duration: 5 hours).', 'description': 'EPOC will be assessed during the hours following the before-mentioned specific exercise bouts using the indirect calorimetry ventilated hood technique.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glycemic control', 'excess post-exercise oxygen consumption'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '24905068', 'type': 'DERIVED', 'citation': 'Karstoft K, Christensen CS, Pedersen BK, Solomon TP. The acute effects of interval- Vs continuous-walking exercise on glycemic control in subjects with type 2 diabetes: a crossover, controlled study. J Clin Endocrinol Metab. 2014 Sep;99(9):3334-42. doi: 10.1210/jc.2014-1837. Epub 2014 Jun 6.'}]}, 'descriptionModule': {'briefSummary': 'Four months of interval walking training (IWT) is superior to energy-expenditure matched continuous walking training (CWT) with regards to weight loss and improvements in glycemic control. The reason for this is unclear. One potential explanation for the differential outcome in weight loss is excess post-exercise oxygen consumption (EPOC), which is defined as the elevated oxygen consumption measured during the hours following an exercise bout. A large EPOC means greater energy expenditure which, if energy intake does not change, leads to a greater weight loss. This weight loss may subsequently improve glycemic control\n\n* Aim 1: To assess the effect of an acute bout of IWT vs. an acute bout of CWT on glycemic control in type 2 diabetics and to assess mechanisms responsible for differences (if any). It is hypothesised that IWT will be more advantageous for improving glycemic control.\n* Aim 2: To examine the effect of an acute bout of IWT vs. an acute bout of CWT on EPOC. It is hypothesised that IWT will produce an EPOC of larger magnitude than CWT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetes mellitus, type 2\n\nExclusion Criteria:\n\n* Smoking\n* Pregnancy\n* insulin dependence\n* Contraindication to physical activity (as judged by medical history and screening)\n* Evidence of thyroid, liver, lung, kidney or heart disease'}, 'identificationModule': {'nctId': 'NCT01987258', 'acronym': 'acute IWS', 'briefTitle': 'The Acute Effect of Interval-walking', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'The Acute Effect of Interval-walking', 'orgStudyIdInfo': {'id': 'H-3-2012-141'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No exercise (control experiment)'}, {'type': 'EXPERIMENTAL', 'label': 'Interval Walking', 'description': 'A one hour interval walking exercise bout', 'interventionNames': ['Behavioral: Interval Walking']}, {'type': 'EXPERIMENTAL', 'label': 'Continuous walking', 'description': 'A one hour continuous walking exercise bout', 'interventionNames': ['Behavioral: Continuous walking']}], 'interventions': [{'name': 'Interval Walking', 'type': 'BEHAVIORAL', 'otherNames': ['Interval exercise', 'Interval training'], 'armGroupLabels': ['Interval Walking']}, {'name': 'Continuous walking', 'type': 'BEHAVIORAL', 'otherNames': ['Continuous exercise', 'Continuous training'], 'armGroupLabels': ['Continuous walking']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Centre of Inflammation and Metabolism (CIM), Rigshospitalet, Tagensvej 20, section M7641', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Kristian Karstoft, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre of Inflammation and Metabolism (CIM), Rigshospitalet, Tagensvej 20, section M7641, DK-2100 Copenhagen, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Administrator', 'investigatorFullName': 'Inge Holm', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}