Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-28 @ 9:43 AM
Study NCT ID:
NCT03868592
Status:
RECRUITING
Last Update Posted:
2025-02-07
First Post:
2019-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term, Substantial Weight Loss and Insulin Regulation of Lipolysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050110', 'term': 'Bariatric Surgery'}], 'ancestors': [{'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Study insulin action and adipose function before and after weight loss from gastric sleeve surgery'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-05', 'studyFirstSubmitDate': '2019-03-07', 'studyFirstSubmitQcDate': '2019-03-08', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Long-term, substantial weight loss and insulin regulation of lipolysis', 'timeFrame': '1 year', 'description': 'Patients will undergo studies of insulin regulation of FFA release combined with adipose biopsies before and one year after bariatric surgery (gastric sleeve). We will relate the improvement in insulin-regulation of lipolysis to changes in adipose tissue lipolysis proteins as measured by changes in adipocyte perilipin 1 dephosphorylation in response to insulin.'}, {'measure': 'Long-term, substantial weight loss and insulin regulation of lipolysis', 'timeFrame': '1 year', 'description': 'Patients will undergo studies of insulin regulation of FFA release combined with adipose biopsies before and one year after bariatric surgery (gastric sleeve). We will relate the improvement in insulin-regulation of lipolysis to changes in adipose tissue lipolysis proteins as measured by changes in adipocyte HSL dephosphorylation in response to insulin.'}], 'primaryOutcomes': [{'measure': 'adipose macrophage content, adipose IL-6 and TNF gene expression', 'timeFrame': 'Before bariatric surgery and approximately 1 year after surgery', 'description': 'Adipose tissue macrophage content as assessed by immunohistochemistry using stains for CD36, CD14 and CD206 will be done. mRNA expression for IL-6 and TNF will be measured'}, {'measure': 'insulin regulation of lipolysis (IC50)', 'timeFrame': 'Before bariatric surgery and approximately 1 year after surgery', 'description': 'The ability of insulin to suppress FFA palmitate release will be assessed using a 2-step insulin clamp and isotope dilution techniques for palmitate kinetics'}], 'secondaryOutcomes': [{'measure': 'adipocyte perilipin 1 and HSL and ATGL', 'timeFrame': 'Before bariatric surgery and approximately 1 year after surgery', 'description': 'These proteins will be measured using capillary Western methods.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity, Morbid']}, 'descriptionModule': {'briefSummary': 'It is not known how much improvement in insulin regulated lipolysis (the breakdown of triglycerides) occurs following substantial, sustained weight loss. Researchers will test the effects of inflammation and lipolysis regulation in people before and after bariatric surgery (sleeve gastrectomy) to answer these questions.', 'detailedDescription': 'The purpose of this study is to determine whether the adipose inflammatory cell and cytokine content in Class III obesity is related to lipolysis insulin resistance and, if so, whether sustained, substantial weight loss one year following bariatric surgery reduces inflammation in parallel with improved insulin regulation of lipolysis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 40 - 50 kg/m2.\n* Mo active physical illness that would interfere with mobility or weight loss after bariatric surgery\n\nExclusion Criteria:\n\n* Type 1 or Type 2 Diabetes diagnosis or fasting plasma glucose ≥126 mg/dL\n* Active coronary artery disease\n* Participation in structured exercise (\\>2 times per week for 30 minutes or longer)\n* Smoking\n* Medications known to affect adipose tissue metabolism (e.g., beta blockers, corticosteroids)\n* Renal insufficiency (serum creatinine \\> 1.5mg/dl)\n* Chronic active liver disease (Bilirubin \\> 17mmol/L, AST \\> 144 IU/L, or ALT\\>165IU/L)\n* Pregnancy or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT03868592', 'briefTitle': 'Long-term, Substantial Weight Loss and Insulin Regulation of Lipolysis', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Long-term, Substantial Weight Loss and Insulin Regulation of Lipolysis', 'orgStudyIdInfo': {'id': '17-005349'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gastric sleeve surgery', 'description': 'before and after weight loss from bariatric surgery', 'interventionNames': ['Procedure: Gastric sleeve/bariatric surgery']}], 'interventions': [{'name': 'Gastric sleeve/bariatric surgery', 'type': 'PROCEDURE', 'description': 'weight loss', 'armGroupLabels': ['Gastric sleeve surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '559055', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Reich Pamela', 'role': 'CONTACT', 'email': 'reich.pamela@mayo.edu', 'phone': '507-255-6062'}, {'name': 'Michael D Jensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Michael D Jensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michael D. Jensen', 'investigatorAffiliation': 'Mayo Clinic'}}}}