Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-26 @ 1:08 AM
Study NCT ID:
NCT04690634
Status:
COMPLETED
Last Update Posted:
2022-09-13
First Post:
2020-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Changes of Body Fat Distribution in Obese Patients With PCOS After LSG
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}], 'ancestors': [{'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': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 153}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-08', 'studyFirstSubmitDate': '2020-12-20', 'studyFirstSubmitQcDate': '2020-12-27', 'lastUpdatePostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAT mass', 'timeFrame': '12 months', 'description': 'visceral adipose tissue (VAT) mass'}], 'secondaryOutcomes': [{'measure': 'BMI', 'timeFrame': '12 months', 'description': 'Body mass index (BMI) was calculated as follows: BMI = (body weight \\[kg\\])/(height \\[m2\\])'}, {'measure': 'FBG', 'timeFrame': '12 months', 'description': 'fasting blood-glucose in mmol/L'}, {'measure': 'PBG', 'timeFrame': 'Baseline and 12 months', 'description': 'postprandial blood-glucose in mmol/L'}, {'measure': 'FINS', 'timeFrame': 'Baseline and 12 months', 'description': 'fasting serum insulin in mU/L'}, {'measure': 'PINS', 'timeFrame': 'Baseline and 12 months', 'description': 'postprandial insulin in mU/L'}, {'measure': 'ALT', 'timeFrame': 'Baseline and 12 months', 'description': 'alanine aminotransferase in U/L'}, {'measure': 'AST', 'timeFrame': 'Baseline and 12 months', 'description': 'aspartate aminotransferase in U/L）'}, {'measure': 'UA', 'timeFrame': 'Baseline and 12 months', 'description': 'Uric acid in umol/L'}, {'measure': 'CR', 'timeFrame': 'Baseline and 12 months', 'description': 'Creatinine in umol/L'}, {'measure': 'LDL-c', 'timeFrame': 'Baseline and 12 months', 'description': 'low-density lipoprotein cholesterol in mmol/L'}, {'measure': 'HDL-c', 'timeFrame': 'Baseline and 12 months', 'description': 'high-density lipoprotein cholesterol in mmol/L'}, {'measure': 'TC', 'timeFrame': 'Baseline and 12 months', 'description': 'Total Cholesterol in mmol/L'}, {'measure': 'TG', 'timeFrame': 'Baseline and 12 months', 'description': 'Triglyceride in mmol/L'}, {'measure': 'WHR', 'timeFrame': 'Baseline and 12 months', 'description': 'waist-to-hip ratio (WHR) were calculated as follows: WHR = (waist circumference \\[cm\\]/(hip circumference \\[cm\\]).'}, {'measure': 'HC', 'timeFrame': 'Baseline and 12 months', 'description': 'Hip circumference'}, {'measure': 'Ferriman-Gallwey score', 'timeFrame': 'Baseline and 12 months', 'description': 'Ferriman-Gallwey score'}, {'measure': 'Menstrual Cycles', 'timeFrame': 'Baseline and 12 months', 'description': 'The number of menstrual cycles per year was defined as the number of menstruations during the last 12 months.'}, {'measure': 'HOMA-IR', 'timeFrame': 'Baseline and 12 months', 'description': 'homeostatic model assessment insulin resistance index'}, {'measure': 'TT', 'timeFrame': 'Baseline and 12 months', 'description': 'total testosterone in nmol/L'}, {'measure': 'FT', 'timeFrame': 'Baseline and 12 months', 'description': 'free testosterone (nmol/L)'}, {'measure': 'DHEAS', 'timeFrame': 'Baseline and 12 months', 'description': 'Dehydroepiandrosterone Sulfate (ug/dl)'}, {'measure': 'SHBG', 'timeFrame': 'Baseline and 12 months', 'description': 'sex hormone-binding globulin in nmol/L'}, {'measure': 'FSH', 'timeFrame': 'Baseline and 12 months', 'description': 'follicle-stimulating hormone in IU/L'}, {'measure': 'LH', 'timeFrame': 'Baseline and 12 months', 'description': 'luteinizing hormone in IU/L'}, {'measure': 'WC', 'timeFrame': 'Baseline and 12 months', 'description': 'waist circumference,'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laparoscopic Sleeve Gastrectomy', 'Body fat distribution', 'Dual-energy X-ray absorptiometry', 'Visceral adipose tissue'], 'conditions': ['Polycystic Ovary Syndrome']}, 'referencesModule': {'references': [{'pmid': '34152560', 'type': 'BACKGROUND', 'citation': 'Cai M, Gao J, Du L, Cheng X, Zhou D, Zhu J, Qu S, Zhang M. The Changes in Body Composition in Obese Patients with Polycystic Ovary Syndrome after Laparoscopic Sleeve Gastrectomy:a 12-Month Follow-up. Obes Surg. 2021 Sep;31(9):4055-4063. doi: 10.1007/s11695-021-05496-6.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/34152560/', 'label': 'The Changes in Body Composition in Obese Patients with Polycystic Ovary Syndrome after Laparoscopic Sleeve Gastrectomy:a 12-Month Follow-up'}]}, 'descriptionModule': {'briefSummary': 'Polycystic ovary syndrome (PCOS) is a common endocrine disorder, with a prevalence of 5% to 15% in premenopausal women. Patients with PCOS presents as abnormal menstruation, ovulation disorders and/or hyperandrogenemia, and often accompanied by insulin resistance and other metabolic abnormalities. Abdominal fat accumulation, overweightness and obesity are frequently present in patients with PCOS . Visceral adipose tissue (VAT) plays an important role in the pathogenesis of PCOS.Therefore，this study aim to investigate the changes of body fat distribution in obese women with PCOS after laparoscopic sleeve gastrectomy (LSG), and to explore the factors that may predict the changes in body fat distribution in PCOS patients after LSG.', 'detailedDescription': "This study consecutively enrolled 153 patients with obesity aged 18-45 years (83 with PCOS and 70 control patients) who underwent LSG from May 2013 to September 2020 at the Department of Endocrinology, Shanghai Tenth People's Hospital, with a 12-month follow-up. Dual-energy X-ray absorptiometry (DEXA) was used to assess body fat distribution."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Fmale aged 18- 45;\n2. Meet Rotterdam criteria(2003);\n3. body mass index (BMI)≥30 kg/m2\n\nExclusion Criteria:\n\n1. Gender is male;\n2. Younger than 18 years old or older than 45 years old ;\n3. secondary obesity due to endocrine disorders;\n4. history of malignant tumors; 5）sever hepatic and renal disease;\n\n6\\) concurrent participation in other clinical trials; 7) sever endocrine and hereditary diseases; 8) mental illnesses that rendered them unable to provide informed consent; 9) patients declining to undergo complete study testing.'}, 'identificationModule': {'nctId': 'NCT04690634', 'briefTitle': 'The Changes of Body Fat Distribution in Obese Patients With PCOS After LSG', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 10th People's Hospital"}, 'officialTitle': 'The Changes of Body Fat Distribution in Obese Patients With Polycystic Ovary Syndrome After Laparoscopic Sleeve Gastrectomy', 'orgStudyIdInfo': {'id': 'PCOS DEXA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PCOS group', 'description': 'obese female patients with Polycystic ovary syndrome. All participants underwent laparoscopic sleeve gastrectomy (LSG)', 'interventionNames': ['Procedure: laparoscopic sleeve gastrectomy (LSG)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'obese female patients without Polycystic ovary syndrome. All participants underwent laparoscopic sleeve gastrectomy (LSG)', 'interventionNames': ['Procedure: laparoscopic sleeve gastrectomy (LSG)']}], 'interventions': [{'name': 'laparoscopic sleeve gastrectomy (LSG)', 'type': 'PROCEDURE', 'description': 'Multiple studies have indicated that laparoscopic sleeve gastrectomy (LSG) was superior to nonsurgical approaches for the treatment of obese PCOS patients over both the short and long term', 'armGroupLabels': ['PCOS group', 'control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200070', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Department of Endocrinology, Shanghai Tenth People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Shen Qu, Dr', 'role': 'STUDY_CHAIR', 'affiliation': "Shang hai Tenth People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai 10th People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Principal Investigator, Clinical Professor', 'investigatorFullName': 'Zhang Manna', 'investigatorAffiliation': "Shanghai 10th People's Hospital"}}}}