Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-02-04 @ 2:28 AM
Study NCT ID:
NCT04548232
Status:
COMPLETED
Last Update Posted:
2022-09-14
First Post:
2020-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Efficacy and Safety of a Laparoscopic Sleeve Gastrectomy in Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D000052', 'term': 'Acanthosis Nigricans'}, {'id': 'D033461', 'term': 'Hyperuricemia'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'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': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D008548', 'term': 'Melanosis'}, {'id': 'D017495', 'term': 'Hyperpigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-10', 'studyFirstSubmitDate': '2020-09-07', 'studyFirstSubmitQcDate': '2020-09-07', 'lastUpdatePostDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hepatic steatosis', 'timeFrame': '3 years', 'description': 'hepatic steatosis assessed by FibroScan(CAP value and E value)'}], 'secondaryOutcomes': [{'measure': 'BMI', 'timeFrame': '3 years', 'description': 'BMI=weight(kg)/height(m)\\^2'}, {'measure': 'Menstrual cycles', 'timeFrame': '3 years', 'description': 'the total number of menstrual periods in the last year'}, {'measure': 'Waist/hip Ratio', 'timeFrame': '3 years', 'description': 'WHR=Waist Circumference in centimeter/Hip Circumference in centimeter'}, {'measure': 'TT', 'timeFrame': '3 years', 'description': 'total testosterone in nmol/L'}, {'measure': 'FBG', 'timeFrame': '3 years', 'description': 'fasting blood-glucose in mmol/L'}, {'measure': 'PBG', 'timeFrame': '3 years', 'description': 'postprandial blood-glucose in mmol/L'}, {'measure': 'FINS', 'timeFrame': '3 years', 'description': 'fasting serum insulin in mU/L'}, {'measure': 'PINS', 'timeFrame': '3 years', 'description': 'postprandial insulin in mU/L'}, {'measure': 'ALT', 'timeFrame': '3 years', 'description': 'alanine aminotransferase in U/L'}, {'measure': 'AST', 'timeFrame': '3 years', 'description': 'aspartate aminotransferase in U/L'}, {'measure': 'UA', 'timeFrame': '3 years', 'description': 'Uric acid in umol/L'}, {'measure': 'HOMA-IR', 'timeFrame': '3 years', 'description': 'Homeostatic model assessment insulin resistance index=FBG\\*FINS/22.5'}, {'measure': 'HbA1c (%)，', 'timeFrame': '3 years', 'description': 'Glycated hemoglobin'}, {'measure': 'SHBG', 'timeFrame': '3 years', 'description': 'sex hormone-binding globulin in nmol/L'}, {'measure': 'FT', 'timeFrame': '3 years', 'description': 'free testosterone (nmol/L)'}, {'measure': 'DHEAS', 'timeFrame': '3 years', 'description': 'Dehydroepiandrosterone Sulfate (ug/dl)'}, {'measure': 'LDL-C', 'timeFrame': '3 years', 'description': 'low-density lipoprotein cholesterol in mmol/L、'}, {'measure': 'HDL-C', 'timeFrame': '3 years', 'description': 'Hight-density lipoprotein cholesterol in mmol/L、'}, {'measure': 'Fertility', 'timeFrame': '3 years', 'description': 'sexual function, fertility'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laparoscopic sleeve Gastrectomy', 'Nonalcoholic Fatty Liver', 'Type 2 Diabetes', 'Polycystic Ovary Syndrome', 'Acanthosis nigricans', 'Hyperuricemia', 'Hyperinsulinemia', 'Sleep apnea Syndrome'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '39511506', 'type': 'DERIVED', 'citation': 'Wang X, Fang Y, Huang X, Du L, Ren H, Sheng C, Yang P, Huang Y, Qu S. Relationship of serum iron and thyroid hormone in obesity and after laparoscopic sleeve gastrectomy. BMC Endocr Disord. 2024 Nov 7;24(1):240. doi: 10.1186/s12902-024-01753-8.'}, {'pmid': '35399676', 'type': 'DERIVED', 'citation': 'Ma B, Yang P, Gao J, Du L, Sheng C, Usman T, Wang X, Qu S. Relationship of Vitamin A and Thyroid Function in Individuals With Obesity and After Laparoscopic Sleeve Gastrectomy. Front Nutr. 2022 Mar 15;9:824193. doi: 10.3389/fnut.2022.824193. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'This study aim to evaluate the clinical efficacy and safety after laparoscopic sleeve gastrectomy in patients with obesity. 300 patients with obesity and 49 healthy individuals with normal BMI were enrolled.', 'detailedDescription': 'This study aim to evaluate the clinical efficacy and safety after laparoscopic sleeve gastrectomy in patients with obesity. 300 patients with obesity and 49 healthy individuals with normal BMI were enrolled.\n\nAll patients with obesity underwent LSG. A multidisciplinary team evaluated participants with obesity at baseline, 1, 3, 6, 12, 24, and 36 months after LSG. Anthropometrics, Metabolic indicators, sex hormones, menstruation，glucose-lipid metabolic markers, and hepatic steatosis assessed by FibroScan(CAP value and E value) were measured baseline and postoperative.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '300 subjects with obesity or overweight', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\) age ranged from 16\\~65 years old, 2) BMI over 37.5 kg/m2, or BMI over 32.5 kg/m2 with diabetes which meets the recommended cutoff for bariatric surgery of the Guidelines for surgical treatment of obesity accompanied with or without type 2 diabetes in China. -\n\nExclusion Criteria:\n\n* 1\\) secondary cause of obesity such as hypothalamic obesity, Cushing syndrome, and hypophysis dysfunction, etc., 2) pregnancy or lactation, 3) contraindications for laparoscopic surgery, such as gastrointestinal diseases of intra-abdominal infection, adhesions, etc., 4) severe heart, liver and kidney dysfunction, 5) organic and systemic diseases intolerant of surgery.'}, 'identificationModule': {'nctId': 'NCT04548232', 'briefTitle': 'Clinical Efficacy and Safety of a Laparoscopic Sleeve Gastrectomy in Obese Patients', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 10th People's Hospital"}, 'officialTitle': "Shanghai Tenth People's Hospital，School of Medicine, Tongji University", 'orgStudyIdInfo': {'id': 'LSG in Obese Patients'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'LSG in obese', 'description': 'Patients with obesity underwent LSG. Divided into simple obese patients (without complications) and obese patients with complications', 'interventionNames': ['Procedure: Laparoscopic sleeve gastrectomy']}, {'label': 'Control group', 'description': 'healthy individuals with normal BMI'}], 'interventions': [{'name': 'Laparoscopic sleeve gastrectomy', 'type': 'PROCEDURE', 'description': 'bariatric surgery', 'armGroupLabels': ['LSG in obese']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai 10th People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Shen Qu', 'investigatorAffiliation': "Shanghai 10th People's Hospital"}}}}