Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2026-01-03 @ 10:12 PM
Study NCT ID:
NCT00666861
Status:
TERMINATED
Last Update Posted:
2009-07-30
First Post:
2008-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Type 2 Diabetes and Exercise - A Pilot Study
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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Pilot study superseded by a larger NHMRC funded trial', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-28', 'studyFirstSubmitDate': '2008-04-23', 'studyFirstSubmitQcDate': '2008-04-24', 'lastUpdatePostDateStruct': {'date': '2009-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'A randomised, cross-over trial targeting a small sample of older (age 45-65 years) overweight adults with type 2 diabetes the aims of this pilot study are to:\n\n1. Determine the feasibility of investigating the acute effects of prolonged sedentary behaviour (sitting) in this target group.\n2. Compare the acute effects of a single prolonged (8 hour) bout of sedentary behaviour (sitting) on glucose and triglyceride concentrations and key muscle and adipose regulatory enzymes to a similar bout of sedentary behaviour combined with intermittent bouts of light-intensity activity.', 'detailedDescription': 'The proposed study will involve a randomised cross-over experimental trial conducted in the laboratory setting in older overweight adults with type 2 diabetes. Participants will receive both of the acute testing conditions in a randomised manner.\n\nStudy design: Randomised cross-over pilot trial of 20 overweight/obese older adults with diet-controlled type 2 diabetes involving 2 acute treatment conditions, with a one-week wash-out period between testing conditions (Figure 1 a).\n\nSetting: Acute, supervised laboratory setting within the Alfred and Baker Heart Institute Medical Unit.\n\nOutcomes: We will measure acute responses in laboratory-measured plasma glucose \\& triglyceride levels (every 60 mins) and glucose concentrations determined from continuous glucose monitoring (CGMS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Type 2 Diabetes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diet controlled Diabetes\n2. Overweight (BMI \\> 27 kg/m2 but \\<50 kg/m2)\n\nExclusion Criteria:\n\n1. Hypoglycaemic Agents\n2. Lipid Lowering Agents'}, 'identificationModule': {'nctId': 'NCT00666861', 'briefTitle': 'Type 2 Diabetes and Exercise - A Pilot Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bayside Health'}, 'officialTitle': 'Understanding the Acute Effects of Prolonged Sedentary Behaviour (Sitting) on Post-meal Glucose and Lipids - A Pilot Study', 'orgStudyIdInfo': {'id': '290/07'}}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Bronwyn A Kingwell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baker Heart Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayside Health', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'International Diabetes Institute, Australia', 'class': 'OTHER'}, {'name': 'Baker Heart Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Assoc/Prof Bronwyn Kingwell - Executive Director Science Policy and Head, Clinical Physiology', 'oldOrganization': 'Baker Heart Research Institute'}}}}