Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT07239167
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-11-20
First Post:
2025-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective Cohort Study on Patient With Obesity Undergoing Weight Reduction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2035-05-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-16', 'studyFirstSubmitDate': '2025-11-16', 'studyFirstSubmitQcDate': '2025-11-16', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-04-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Baseline data were collected and followed up during the subjects' initial visit to the weight loss clinic to establish an evidence-based basis for personalized weight loss treatment.", 'timeFrame': 'Weight loss changes of subjects after 24 weeks, 48 weeks, 72 weeks, and 96 weeks.'}]}, 'conditionsModule': {'conditions': ['Obesity & Overweight', 'Weight Loss', 'Metabolic Syndrome', 'Metabolic Dysfunction-Associated Steatohepatitis', 'Obesity (Disorder)']}, 'descriptionModule': {'briefSummary': 'This prospective cohort study collected baseline data and followed up obese patients at their first visit to a weight loss clinic. The study examined the impact of various predictors and biomarkers on weight loss outcomes, aiming to establish an evidence-based foundation for personalized weight loss treatment.\n\nParticipants underwent a battery of measurements and questionnaires, including height, weight, waist circumference, blood pressure, blood tests, and questionnaires addressing diet, exercise, stress, sleep, and psychological well-being.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participate were first diagnosed at the weight loss clinic at the National Taiwan University Hospital.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults aged 18 years or older, regardless of gender.\n2. Body mass index (BMI) ≥ 27 kg/m², or ≥ 24 kg/m² with one or more obesity-related comorbidities.\n3. Willing to undergo any form of weight loss intervention.\n4. Able to read and understand Chinese, willing to complete questionnaires, blood tests, and follow-up follow-up.\n5. Voluntarily consent to participate and be willing to complete the subject consent form.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women.\n2. Individuals with significant mental illness (e.g., schizophrenia, severe depression) or cognitive impairment that may affect their ability to consent or cooperate with the study.\n3. Individuals with severe organ dysfunction (e.g., end-stage renal disease, cirrhosis, congestive heart failure, etc.).\n4. Individuals taking medications that significantly affect their weight (e.g., long-term steroids or antipsychotics) and cannot be discontinued.\n5. Individuals deemed unsuitable for participation in this study by the study leader (e.g., individuals who are expected to be unable to complete follow-up).'}, 'identificationModule': {'nctId': 'NCT07239167', 'briefTitle': 'A Prospective Cohort Study on Patient With Obesity Undergoing Weight Reduction', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'A Prospective Cohort Study on Patient With Obesity Undergoing Weight Reduction', 'orgStudyIdInfo': {'id': '202504134RINA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A prospective cohort study on patients with obesity undergoing weight reduction'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'state': 'Zhongzheng Dist', 'country': 'Taiwan', 'facility': 'No.7, Chung Shan S. Rd.（Zhongshan S. Rd.）', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}