Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT06182618
Status:
UNKNOWN
Last Update Posted:
2023-12-27
First Post:
2023-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Retrospective Analysis for Patients With Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-24', 'studyFirstSubmitDate': '2023-11-30', 'studyFirstSubmitQcDate': '2023-12-24', 'lastUpdatePostDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'weight', 'timeFrame': '0month/1month/2months/3 months', 'description': 'Weight was measured through multi-frequency bioelectrical impedance analysis InBody 720 (Bio Space Co., Seoul, Korea) at various time points'}], 'secondaryOutcomes': [{'measure': 'visceral fat area(VFA)', 'timeFrame': '0month/1month/2months/3 months', 'description': 'VFA was measured through multi-frequency bioelectrical impedance analysis InBody 720 (Bio Space Co., Seoul, Korea) at various time points'}, {'measure': 'skeletal muscle mass(SMM)', 'timeFrame': '0month/1month/2months/3 months', 'description': 'SMM was measured through multi-frequency bioelectrical impedance analysis InBody 720 (Bio Space Co., Seoul, Korea) at various time points'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'The incidence of metabolic syndrome and related diseases is gradually increasing, and diet and medication are currently common outpatient treatment methods. This study retrospectively analyzes the clinical data of patients with metabolic syndrome and related diseases who have visited our outpatient department in the past 10 years, compares the therapeutic effects of different treatment methods on their blood glucose, blood lipids, blood pressure, uric acid, and body composition, and provides evidence support for clinical treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This was a retrospective study of the weight loss effect in 1 to 3 months in overweight or obese individuals at the department of clinical nutrition in the Second Affiliated Hospital of Zhejiang University, School of Medicine in China between 1 January 2020 and 1 Janu-ary 2024.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• individuals who had at least a 2 follow up visits with a BMI of 24 or more with the pri-mary goal of losing weight.\n\nExclusion Criteria:\n\n* patients did not follow-up on a monthly basis;\n* patients followed-up less than 1 times within 3 months;\n* patients having incomplete data;\n* patients changing their interventions during fol-low-ups'}, 'identificationModule': {'nctId': 'NCT06182618', 'briefTitle': 'Retrospective Analysis for Patients With Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Retrospective Analysis of Outpatient Intervention Effects in Patients With Metabolic Syndrome', 'orgStudyIdInfo': {'id': '2023-1042'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'low-carbohydrate diet', 'description': '20-30% carbohydrates, 40-45%fat, and 30-40%protein', 'interventionNames': ['Other: dietary, semaglutide or/and metformin']}, {'label': 'balanced diet', 'description': '50-65% carbohydrate, 20-30% fat and 10-20% protein', 'interventionNames': ['Other: dietary, semaglutide or/and metformin']}, {'label': 'pharmacotherapy', 'description': 'semaglutide (1mg per week) or/and metformin (o.5g three times a day)', 'interventionNames': ['Other: dietary, semaglutide or/and metformin']}], 'interventions': [{'name': 'dietary, semaglutide or/and metformin', 'type': 'OTHER', 'description': 'patients were prescribed dietary and pharmaceuticals for weight loss', 'armGroupLabels': ['balanced diet', 'low-carbohydrate diet', 'pharmacotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'wang leilei', 'role': 'CONTACT', 'email': '2513118@zju.edu.cn', 'phone': '15968860233'}], 'facility': 'The Second Affiliated Hospital, College of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'leilei wang', 'role': 'CONTACT', 'email': '2513118@zju.edu.cn', 'phone': '0571-87783851'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}