Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2025-12-24 @ 4:38 PM
Study NCT ID:
NCT06831266
Status:
RECRUITING
Last Update Posted:
2025-02-21
First Post:
2025-01-29
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Exercise Prediabetic Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011236', 'term': 'Prediabetic State'}, {'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'}]}, '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', 'maskingDescription': 'Masked for biomarker evaluation'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-19', 'studyFirstSubmitDate': '2025-01-29', 'studyFirstSubmitQcDate': '2025-02-14', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbAc', 'timeFrame': '12 weeks', 'description': 'It is the amount of glycosylated hemoglobin in the blood.'}], 'secondaryOutcomes': [{'measure': 'HDL', 'timeFrame': '12 weeks', 'description': 'It is the amount of high-density lipoprotein in the blood.'}, {'measure': 'LDL level LDL', 'timeFrame': '12 weeks', 'description': 'It is the amount of low-density lipoprotein in the blood.'}, {'measure': 'CRP', 'timeFrame': '12 weeks', 'description': 'C-reactive protein is a protein produced in the liver.'}, {'measure': 'Total cholesterol', 'timeFrame': '12 weeks', 'description': 'Cholesterol is a lipid that is necessary for the construction of cell membranes in the body and the production of some hormones and vitamin D.'}, {'measure': 'Triglyceride', 'timeFrame': '12 weeks', 'description': "It is a type of fat molecule found in the bloodstream and is used as the body's energy source."}, {'measure': 'Irisin', 'timeFrame': '12 weeks', 'description': 'Irisin, defined as a myokine, is the proteolytic product of fibronectin type III domain 5 protein.'}, {'measure': 'Adiponectin', 'timeFrame': '12 weeks', 'description': 'Adiponectin is a protein hormone and adipokine, which is involved in regulating glucose levels and fatty acid breakdown.'}, {'measure': 'IL-6', 'timeFrame': '12 weeks', 'description': 'Interleukin-6 is an endogenous chemical involved in inflammation and B cell maturation.'}, {'measure': 'Resistin', 'timeFrame': '12 weeks', 'description': 'Resistin is a hormone secreted from fat cells.'}, {'measure': 'Kemerin', 'timeFrame': '12 weeks', 'description': 'It is a protein that is involved in many metabolic events such as adipogenesis, angiogenesis and glucose homeostasis, including the chemoattractant function of the belt.'}, {'measure': 'Osteocalcin', 'timeFrame': '12 weeks', 'description': 'Osteocalcin is a bone-specific protein found in osteoblasts.'}, {'measure': 'Leptin', 'timeFrame': '12 weeks', 'description': 'Leptin is a hormone that acts on the hypothalamus through negative feedback secreted from fat cells, suppressing food intake and increasing energy expenditure.'}, {'measure': 'TNF-alpha', 'timeFrame': '12 weeks', 'description': 'Tumor necrosis factor alpha is a chemical messenger produced by the immune system that initiates inflammation.'}, {'measure': 'Cardiometabolic risk level', 'timeFrame': '12 weeks', 'description': 'Cardiometabolic risk has been defined as a cluster of metabolic and cardiovascular abnormalities, including abdominal obesity, insulin resistance, hypertension, dyslipidemia, and atherosclerosis, that predispose individuals to cardiovascular disease and type 2 diabetes.'}, {'measure': 'Body composition', 'timeFrame': '12 weeks', 'description': 'Body composition describes the amount of fat, bone, water and muscle in the body.'}, {'measure': 'Aerobic capacity', 'timeFrame': '12 weeks', 'description': 'Aerobic capacity is the capacity of large striated muscle groups to adapt to work using energy obtained from aerobic metabolism.'}, {'measure': 'Exercise Health Belief Model Scale', 'timeFrame': '12 weeks', 'description': 'Exercise Health Belief Model Scale is a 5-point Likert-type scale consists of 32 items.The scale consists of 5 factors and there is no reverse item. The highest and lowest score on the scale is 160 and 32, respectively. Higher scores indicate higher level of exercise health belief.'}, {'measure': 'Short Form-36 Questionnaire', 'timeFrame': '12 weeks', 'description': 'The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. SF-36 measures eight scales: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health.Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. High scores indicate good health status.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['exercise', 'anti-inflammatory markers', 'aerobic capacity'], 'conditions': ['Prediabetes / Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to determine the effects of two different exercise protocols on body composition, aerobic capacity, blood lipid profile, some biomarkers, quality of life and exercise beliefs in participants at risk of diabetes.', 'detailedDescription': 'After being informed about the study and possible risks, all participants who gave written informed consent and met the eligibility requirements will be randomly assigned to 2 separate groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being between 18-60 years old\n* HbA1c value between 5.7%-6.4%\n* BMI\\>24,9 kg/m²\n* Being sedentary\n* Not on any diet\n\nExclusion Criteria:\n\n* Insulin and derivative drug use\n* Uncontrolled hypertension\n* History of heart disease\n* History of MI or stroke'}, 'identificationModule': {'nctId': 'NCT06831266', 'briefTitle': 'Effects of Exercise Prediabetic Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Eastern Mediterranean University'}, 'officialTitle': 'Comparison of the Effects of High-Intensity Interval Exercise Training and Moderate-Intensity Continuous Exercise Training in Prediabetic Individuals: Single-Blind Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'ETK00-2023-0184'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HIIT High Intensity Interval Training', 'description': 'High-intensity interval training (HIIT) is a type of training that involves repeated bouts of high intensity effort interspersed by recovery times.', 'interventionNames': ['Other: High Intensity Interval Training (HIIT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MICT Moderate Intensity Continuous Training', 'description': 'Moderate Intensity Continuous Training (MICT) consists of performing aerobic exercise at a constant and moderate intensity for a prolonged duration.', 'interventionNames': ['Other: Moderate Intensity Continuous Training (MICT)']}], 'interventions': [{'name': 'High Intensity Interval Training (HIIT)', 'type': 'OTHER', 'otherNames': ['High Intensity Interval Training'], 'description': '1 minute interval, 1 minute active recovery\n\n5 minutes warm-up - 3 minutes cool-down will be done at 60% of peak heart rate.\n\nWeeks 1-2: Loading at an intensity of 85% of peak heart rate, active recovery at an intensity of 60% of peak heart rate 4x1\n\nWeeks 2-7: Loading at an intensity of 90% of peak heart rate, active recovery at an intensity of 60% of peak heart rate 6x1\n\nWeeks 8-12: Loading at an intensity of 90% of peak heart rate, active recovery at an intensity of 60% of peak heart rate 8x1', 'armGroupLabels': ['HIIT High Intensity Interval Training']}, {'name': 'Moderate Intensity Continuous Training (MICT)', 'type': 'OTHER', 'otherNames': ['Moderate Intensity Continuous Training'], 'description': '5 minutes warm-up - 3 minutes cool-down will be done at 60% of peak heart rate.\n\nWeeks 1-2: Loading at 65% of peak heart rate intensity (22 minute)\n\nWeeks 2-7: Loading at 75% of peak heart rate intensity (30 minute)\n\nWeeks 8-12: Loading at 75% of peak heart rate intensity (38 minute)', 'armGroupLabels': ['MICT Moderate Intensity Continuous Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99300', 'city': 'Mersin', 'state': 'Kyrenia', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Emine Ahsen Şenol, MSc', 'role': 'CONTACT', 'email': 'emineahsen.senol@kyrenia.edu.tr', 'phone': '+90 533 859 31 18'}], 'facility': 'University of Kyrenia Hospital', 'geoPoint': {'lat': 36.81196, 'lon': 34.63886}}, {'zip': '33010', 'city': 'Mersin', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Yasin YURT, Asst. Prof.', 'role': 'CONTACT', 'email': 'fzt.yasinyurt@gmail.com', 'phone': '+90 533 872 4271'}, {'name': 'Emine Ahsen ŞENOL, MSc', 'role': 'CONTACT', 'email': 'senolahsen@gmail.com', 'phone': '+90 533 859 3118'}], 'facility': 'Eastern Mediterranean University', 'geoPoint': {'lat': 36.81196, 'lon': 34.63886}}], 'centralContacts': [{'name': 'Emine Ahsen Şenol', 'role': 'CONTACT', 'email': 'emineahsen.senol@kyrenia.edu.tr', 'phone': '+90 533 859 31 18'}, {'name': 'Yasin Yurt', 'role': 'CONTACT', 'email': 'yasin.yurt@emu.edu.tr', 'phone': '+90 533 872 42 71'}], 'overallOfficials': [{'name': 'Mehtap Malkoç', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eastern Mediterranean University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eastern Mediterranean University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Ahsen Şenol', 'investigatorAffiliation': 'University of Kyrenia'}}}}