Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT05052918
Status:
UNKNOWN
Last Update Posted:
2022-06-22
First Post:
2021-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Exercise and Metformin on Carotid Intima-media Thickness in Patients With Prediabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018149', 'term': 'Glucose Intolerance'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D011236', 'term': 'Prediabetic State'}], 'ancestors': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2023-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-19', 'studyFirstSubmitDate': '2021-09-07', 'studyFirstSubmitQcDate': '2021-09-12', 'lastUpdatePostDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Carotid ultrasound', 'timeFrame': '12 weeks', 'description': 'milimeter size of carotid intima media thickness'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prediabetes', 'exercise', 'metformin', 'atherosclerosis'], 'conditions': ['Pre Diabetes', 'Exercise', 'Metformin', 'Atherosclerosis']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate whether there is a change in carotid intima media thickness with the application of guide-based exercise programs in individuals with prediabetes, and to evaluate whether there is a difference between the group in which exercise programs were applied and those who received only lifestyle change and metformin.', 'detailedDescription': 'The researchers think that the application of guide-based exercise programs in prediabetes patients will decrease the carotid intima-media thickness.The aim of this study is to evaluate whether there is a change in carotid intima media thickness with the application of guide-based exercise programs in individuals with prediabetes, and to evaluate whether there is a difference between the group in which exercise programs were applied and those who received only lifestyle change and metformin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Leading a sedentary life\n* Those who have sufficient motivation to participate in the exercise program (will be evaluated by a one-on-one interview by the researchers)\n* Have the same weight for 6 months before participating in the study (±2.5 kg)\n* Those diagnosed with prediabetes by oral glucose tolerance test and/or HbA1c measurement\n\nExclusion Criteria:\n\n* Serious medical condition (for example, advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.) that would prevent the person from participating in exercise training.\n* Having cardiovascular disease\n* Being diabetic\n* Using metformin before participating in the study\n* Receiving hormone replacement therapy\n* Life expectancy less than 1 year\n* HIV positivity\n* Substance use\n* Functional dependency\n* Cognitive weakness\n* Those who have other diseases that will affect the results of the study (respiratory diseases, muscle diseases, etc.)\n* Those who use drugs or supplements that will affect the results of the study'}, 'identificationModule': {'nctId': 'NCT05052918', 'briefTitle': 'The Effect of Exercise and Metformin on Carotid Intima-media Thickness in Patients With Prediabetes', 'organization': {'class': 'OTHER', 'fullName': 'Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey'}, 'officialTitle': 'The Effect of Exercise and Metformin on Carotid Intima-media Thickness in Patients With Prediabetes', 'orgStudyIdInfo': {'id': 'EXERCISECIMT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise', 'description': 'Patients with prediabetes undergoing a 12-week exercise program\n\n(1 hour of moderate-intensity aerobic exercise 3 days a week for 12 weeks)', 'interventionNames': ['Behavioral: Exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients with prediabetes with no intervention'}, {'type': 'NO_INTERVENTION', 'label': 'Metformin', 'description': 'Patients with prediabetes using metformin'}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': '1 hour of moderate-intensity aerobic exercise 3 days a week for 12 weeks', 'armGroupLabels': ['Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34668', 'city': 'Üsküdar', 'state': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Elif Yıldırım Ayaz, M.D.', 'role': 'CONTACT', 'email': 'drelifyildirim@hotmail.com', 'phone': '+905325148300'}, {'name': 'Emine Şeyma Denli Yalvaç, M.D.', 'role': 'CONTACT', 'email': 'seymadenli@gmail.com', 'phone': '+905057311317'}], 'facility': 'Sultan Abdülhamid Han Training and Research Hospital', 'geoPoint': {'lat': 41.02274, 'lon': 29.01366}}], 'centralContacts': [{'name': 'Elif Yıldırım Ayaz, M.D.', 'role': 'CONTACT', 'email': 'drelifyildirim@hotmail.com', 'phone': '+905325148300'}, {'name': 'Emine Şeyma Denli Yalvaç, M.D.', 'role': 'CONTACT', 'email': 'seymadenli@gmail.com', 'phone': '+905057311317'}], 'overallOfficials': [{'name': 'Elif Yıldırım Ayaz, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sultan Abdülhamid Han Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}