Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2026-02-25 @ 5:49 PM
Study NCT ID:
NCT02592616
Status:
UNKNOWN
Last Update Posted:
2016-06-22
First Post:
2015-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interval-training and Appetite Regulation 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': 'D009043', 'term': 'Motor Activity'}], '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': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-21', 'studyFirstSubmitDate': '2015-10-28', 'studyFirstSubmitQcDate': '2015-10-29', 'lastUpdatePostDateStruct': {'date': '2016-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ad-libitum meal energy intake', 'timeFrame': 'Initiated 3 hours after the intervention', 'description': 'Subjects will receive a standardized ad-libitum meal and energy intake will be assessed'}], 'secondaryOutcomes': [{'measure': 'Free-living energy intake', 'timeFrame': 'For 32 hours following the ad-libitum meal.', 'description': 'Subjects will complete diet records for 32 hours following the ad-libitum meal and energy intake will be assessed.'}, {'measure': 'Appetite-related hormones', 'timeFrame': 'Regularly during the 3 hours following the intervention', 'description': 'Appetite-related hormones (insulin, ghrelin, leptin, cholecyctokinin, PYY) will be analysed in blood samples collected regularly during the liquid mixed-meal tolerance test following the intervention'}, {'measure': 'Satiety', 'timeFrame': 'Regular assessments for 36 hours following the intervention', 'description': 'Satiety questionaires will be completed at regular intervals after the intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Exercise', 'Appetite', 'Energy intake'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'Four months of interval walking (IW) training results in substantial weight loss in opposition to energy-expenditure matched continuous walking (CW) training. The reason for this is unclear.\n\nThis study will assess if IW leads to greater exercise-induced suppression of appetite and ad libitum food intake compared to CW and no exercise.\n\nSubjects with type 2 diabetes will be included in a crossover, counter-balanced, controlled study, where each subject will undergo three trials. Trials will be identical except the following interventions:\n\n1. One hour of rest (CON)\n2. One hour of interval walking (repeated cycles of 3 min of fast and 3 min of slow walking; IW)\n3. One hour of continuous walking (CW) matched to IW with regards to energy-expenditure.\n\nAfter the interventions subjects will undergo a liquid mixed meal tolerance test (450 kCal), with regular measurements of appetite-related hormones (insulin, ghrelin, Leptin, Cholecystokinin, PYY). Three hours into the mixed meal tolerance test, a standardised ad-libitum meal test will be served and intake will recorded. Free-living energy intake via food records will be assessed during the following 32 hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 Diabetes Mellitus\n* BMI \\> 25\n\nExclusion Criteria:\n\n* Pregnancy\n* Smoking\n* Contraindication to increased levels of physical activity\n* Eating disorder\n* Insulin dependence'}, 'identificationModule': {'nctId': 'NCT02592616', 'briefTitle': 'Interval-training and Appetite Regulation in Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Interval-training and Appetite Regulation in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'H-15008542'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CON', 'description': 'Control (CON).', 'interventionNames': ['Behavioral: CON']}, {'type': 'EXPERIMENTAL', 'label': 'CW', 'description': 'Continuous Walking (CW).', 'interventionNames': ['Behavioral: CW']}, {'type': 'EXPERIMENTAL', 'label': 'IW', 'description': 'Interval Walking (IW).', 'interventionNames': ['Behavioral: IW']}], 'interventions': [{'name': 'CON', 'type': 'BEHAVIORAL', 'description': 'No exercise intervention.', 'armGroupLabels': ['CON']}, {'name': 'CW', 'type': 'BEHAVIORAL', 'description': 'One hour of continuous walking on a treadmill.', 'armGroupLabels': ['CW']}, {'name': 'IW', 'type': 'BEHAVIORAL', 'description': 'One hour of interval (repeated cycles of 3 minutes of fast and 3 minutes of slow) walking on treadmill.', 'armGroupLabels': ['IW']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Center for Physical Activity Research (CFAS)', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Anders Rasmussen Rinnov', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}