Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-02-22 @ 7:23 PM
Study NCT ID:
NCT06809257
Status:
COMPLETED
Last Update Posted:
2025-02-05
First Post:
2025-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Exercise on MiR-126 in Individuals With Prediabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011236', 'term': 'Prediabetic State'}, {'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': '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-29', 'studyFirstSubmitDate': '2025-01-23', 'studyFirstSubmitQcDate': '2025-01-29', 'lastUpdatePostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delta CT mir-126', 'timeFrame': '1 week', 'description': 'Ct (cycle threshold) values for miR-126 and miR-16-5p were used for analysis. ΔCt and ΔΔCt values were calculated as follows, and expression levels were analyzed using the 2-ΔΔCt method:\n\n∆Ct = Ct (gene of interest) - Ct (housekeeping gene) ΔΔCt = ∆Ct (treated sample) - ∆Ct (untreated sample) Higher ΔCt values indicate lower expression levels.'}], 'secondaryOutcomes': [{'measure': 'BMI', 'timeFrame': '1 day', 'description': "The BMI is calculated by dividing an adult's weight in kilograms by their height in metres squared."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MiR-126', 'Exercise', 'Prediabetes', 'MicroRNA'], 'conditions': ['Prediabetes', 'microRNA', 'Exercise']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the effect of a structured exercise program on microRNA-126 (miR-126) expression in individuals with prediabetes.', 'detailedDescription': 'This study aims to investigate the effect of a structured exercise program on microRNA-126 (miR-126) expression in individuals with prediabetes. The hypothesis of our study is that regular aerobic exercise will increase miR-126 expression. Determining the effect of exercise on miR-126 in individuals with prediabetes will contribute to the elucidation of the pathways through which exercise is effective in prediabetes via epigenetic mechanisms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals who were newly diagnosed with prediabetes according to the Oral Glucose Tolerance Test (OGTT) and/or HbA1C criteria\n* between the ages of 18-60\n* were physically inactive (Level 1 according to the International Physical Activity Questionnaire)\n* were motivated to exercise\n* Individuals who had no obstacle to exercise as a result of the evaluation made by a cardiologist (ECG, exercise ECG test, etc.)\n* and who did not show a change in body weight of more than ±2.5 kg in the last six months were included in the study.\n\nExclusion Criteria:\n\n* presence of serious medical conditions (e.g. advanced cancer, major neurological or endocrine disorders, respiratory failure)\n* current cardiovascular disease, BMI \\<19 kg/m²\n* history of metformin use within the last 6 months\n* receiving hormone replacement therapy\n* life expectancy less than one year\n* HIV positivity\n* substance use\n* or orthopedic and cognitive disorders that may prevent exercise'}, 'identificationModule': {'nctId': 'NCT06809257', 'acronym': 'EMiR-126-PD', 'briefTitle': 'Effect of Exercise on MiR-126 in Individuals With Prediabetes', 'organization': {'class': 'OTHER', 'fullName': 'Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey'}, 'officialTitle': 'Effect of Exercise on MiR-126 in Individuals With Prediabetes: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'EMiR-126-PD'}, 'secondaryIdInfos': [{'id': 'Saglik Bilimleri University', 'type': 'OTHER', 'domain': 'Saglik Bilimleri University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise', 'description': 'Individuals in the intervention group were included in a planned aerobic exercise program for 12 weeks.This program was carried out under the supervision of specialist doctors, with the help of sports trainers and physiotherapists, and participants were given 60 minutes of moderate-intensity (50-70% of their maximum heart rate) aerobic exercise three days a week.', 'interventionNames': ['Behavioral: Exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No intervention'}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': '12 week moderately aerobik exercise', 'armGroupLabels': ['Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34660', 'city': 'Üsküdar', 'state': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Sultan 2. Abdülhamid Han Training and Research Hospital', 'geoPoint': {'lat': 41.02274, 'lon': 29.01366}}], 'overallOfficials': [{'name': 'Elif Yıldırım Ayaz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sultan 2. Abdülhamid Han Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof. Dr.', 'investigatorFullName': 'Elif Yıldırım Ayaz', 'investigatorAffiliation': 'Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey'}}}}