Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 4:41 AM
Study NCT ID:
NCT00887094
Status:
COMPLETED
Last Update Posted:
2011-08-04
First Post:
2009-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aerobic Training, Aerobic-resistance Training and Glucose Profile (CGMS) in 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'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-03', 'studyFirstSubmitDate': '2009-04-22', 'studyFirstSubmitQcDate': '2009-04-22', 'lastUpdatePostDateStruct': {'date': '2011-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of the prevalence of hyperglycemic peaks during a 24-h period after a bout of aerobic or aerobic/resistance exercise in type 2 diabetes patients on metformin/diet therapy.', 'timeFrame': '24h'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetes mellitus', 'Exercise', 'Endurance', 'Resistance', 'Continuous glucose monitoring system'], 'conditions': ['Diabetes Mellitus, Type 2', 'Treatment', 'Exercise']}, 'referencesModule': {'references': [{'pmid': '23536769', 'type': 'DERIVED', 'citation': 'Figueira FR, Umpierre D, Casali KR, Tetelbom PS, Henn NT, Ribeiro JP, Schaan BD. Aerobic and combined exercise sessions reduce glucose variability in type 2 diabetes: crossover randomized trial. PLoS One. 2013;8(3):e57733. doi: 10.1371/journal.pone.0057733. Epub 2013 Mar 11.'}, {'pmid': '23041227', 'type': 'DERIVED', 'citation': 'Figueira FR, Umpierre D, Ribeiro JP, Tetelbom PS, Henn NT, Esteves JF, Schaan BD. Accuracy of continuous glucose monitoring system during exercise in type 2 diabetes. Diabetes Res Clin Pract. 2012 Dec;98(3):e36-9. doi: 10.1016/j.diabres.2012.09.033. Epub 2012 Oct 4.'}]}, 'descriptionModule': {'briefSummary': 'Many studies were already performed showing beneficial cardiovascular and metabolic effects of physical training for type 2 diabetic patients. However, glucose profile during and immediately after a short period of aerobic and/or resistance training was not studied yet. Continuous glucose monitoring system (CGMS) has now been added to the repertoire of technological devices useful in the management of patients with diabetes. Such monitoring enables clinicians to detect occult hypoglycemia and hyperglycemia not otherwise discernable with intermittent testing of blood glucose. The main aim of the present study is to investigate continuous blood glucose profile (using CGMS) over 72h, beginning 24h before and ending 24h after a single bout of aerobic or aerobic/resistance physical training in type 2 diabetic patients.', 'detailedDescription': 'Many studies were already performed showing beneficial cardiovascular and metabolic effects of physical training for type 2 diabetic patients. However, glucose profile during and immediately after a short period of aerobic and/or resistance training was not studied yet. Continuous glucose monitoring system (CGMS) has now been added to the repertoire of technological devices useful in the management of patients with diabetes. Such monitoring enables clinicians to detect occult hypoglycemia and hyperglycemia not otherwise discernable with intermittent testing of blood glucose. The main aim of the present study is to investigate continuous blood glucose profile (using CGMS) over 72h, beginning 24h before and ending 24h after a single bout of aerobic or aerobic/resistance physical training in type 2 diabetic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetic patients treated with diet and metformin, 35-65 years old\n\nExclusion Criteria:\n\n* Type 1 diabetic patients\n* Treatment with insulin or sulphonylureas or glitazones\n* Proliferative retinopathy\n* Severe autonomic neuropathy\n* Coronary artery disease\n* Baseline fasting plasma glucose\\>200 mg/dl\n* Peripheral artery disease\n* Amputation\n* Heart failure\n* Diabetic nephropathy\n* Renal failure'}, 'identificationModule': {'nctId': 'NCT00887094', 'acronym': 'CGMSexercise', 'briefTitle': 'Aerobic Training, Aerobic-resistance Training and Glucose Profile (CGMS) in Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Clinicas de Porto Alegre'}, 'officialTitle': 'Acute and Subacute Effects of Aerobic Training vs Aerobic/Resistance Training Upon Glucose Profile Evaluated Through Continuous Glucose Monitoring System in Type 2 Diabetes', 'orgStudyIdInfo': {'id': '08-180'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aerobic exercise', 'description': 'One bout of aerobic physical training will be performed on a cycle ergometer for 50 min', 'interventionNames': ['Behavioral: Acute aerobic exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Aerobic-resistance exercise', 'description': 'One bout of aerobic-resistance physical training will be performed on a cycle ergometer added by a strenght training for 50 min (total)', 'interventionNames': ['Behavioral: Acute aerobic-resistance exercise']}], 'interventions': [{'name': 'Acute aerobic exercise', 'type': 'BEHAVIORAL', 'otherNames': ['There are no other names'], 'description': 'Aerobic exercise (on a cycle ergometer, for 50 min)', 'armGroupLabels': ['Aerobic exercise']}, {'name': 'Acute aerobic-resistance exercise', 'type': 'BEHAVIORAL', 'otherNames': ['There are no other names'], 'description': 'Aerobic-resistance exercise (on a cycle ergometer plus strength training, for 50 min in total)', 'armGroupLabels': ['Aerobic-resistance exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90035-003', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital de Clinicas de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'overallOfficials': [{'name': 'Beatriz Schaan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de Clinicas de Porto Alegre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Clinicas de Porto Alegre', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Beatriz Schaan', 'oldOrganization': 'Hospital de Clinicas de Porto Alegre'}}}}