Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2026-01-02 @ 12:11 PM
Study NCT ID:
NCT04232566
Status:
RECRUITING
Last Update Posted:
2025-10-15
First Post:
2019-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating the Link Between Type 2 Immunity and NAFLD in Human Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050110', 'term': 'Bariatric Surgery'}, {'id': 'D015390', 'term': 'Gastric Bypass'}], 'ancestors': [{'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D005763', 'term': 'Gastroenterostomy'}, {'id': 'D000714', 'term': 'Anastomosis, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-14', 'studyFirstSubmitDate': '2019-01-02', 'studyFirstSubmitQcDate': '2020-01-15', 'lastUpdatePostDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Liver fibrosis', 'timeFrame': 'Baseline', 'description': 'evaluate the liver fibrosis by elastography before surgical intervention'}, {'measure': 'Adipose tissue inflammation', 'timeFrame': 'Baseline', 'description': 'Evaluate markers of adipose tissue inflammation by mRNA levels'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obesity', 'nash', 'adipose tissue inflammation', 'insulin resistance'], 'conditions': ['Obesity, Morbid', 'NASH - Nonalcoholic Steatohepatitis', 'Chronic Inflammation']}, 'descriptionModule': {'briefSummary': 'This study is being done to better understand the relationship between inflammation in adipose tissue (AT), abnormal deposition of fat around the liver and how this affects its appearance and function and ultimately insulin resistance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Fourteen subjects with F=0 (no fibrosis) and forty-six patients undergoing gastric bypass Surgery with confirmed Area under the Receiver Operating Characteristic Curve (AUROC) F\\>2 (moderate fibrosis), age 30-70yrs, both genders, BMI greater than 40 kg/m2 will be enrolled in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing gastric bypass surgery\n* Confirmed AUROC F=0 or F\\>2 liver fibrosis\n* Age 30-70 years\n* BMI greater than 40 kg/m2\n* Negative pregnancy test (female only)\n* Lab Values: Normal TSH\n\nExclusion Criteria:\n\n* Autoimmune diseases\n* Hepatitis B or C positive\n* Heavy alcohol use\n* Active smoking history\n* Active cancer history\n* History of asthma\n* History of COPD\n* Taking Plavix or Coumadin\n* Blood donation within past 2 months\n* Glucocorticoid Therapy\n* Taking antihistamine on regular basis'}, 'identificationModule': {'nctId': 'NCT04232566', 'briefTitle': 'Investigating the Link Between Type 2 Immunity and NAFLD in Human Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Investigating the Link Between Type 2 Immunity and NAFLD in Human Obesity- AIM 1', 'orgStudyIdInfo': {'id': '18-004615'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Weight loss surgery', 'description': 'Gastric bypass surgery will be followed by weight loss as standard of care. Liver fibrosis by elastography will be determined before surgery.', 'interventionNames': ['Procedure: Bariatric surgery']}], 'interventions': [{'name': 'Bariatric surgery', 'type': 'PROCEDURE', 'otherNames': ['Roux en Y gastric bypass, sleeve gastrectomy'], 'description': 'Evaluate liver fibrosis by elastography before gastric bypass surgery.', 'armGroupLabels': ['Weight loss surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stewart Keegan', 'role': 'CONTACT', 'email': 'stewart.keegan@mayo.edu', 'phone': '480-301-4164'}, {'name': 'Elena De Filippis, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}], 'centralContacts': [{'name': 'Keegan M Stewart', 'role': 'CONTACT', 'email': 'stewart.keegan@mayo.edu', 'phone': '480-301-4164'}], 'overallOfficials': [{'name': 'Elena Anna O De Filippis', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Elena Anna (Eleanna) De Filippis, M.D., Ph.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}