Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2025-12-29 @ 9:39 PM
Study NCT ID:
NCT04234295
Status:
COMPLETED
Last Update Posted:
2022-01-19
First Post:
2020-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating the Effect of Obesity on Eosinophil Recruitment in Human Adipose Tissue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-01-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-17', 'studyFirstSubmitDate': '2020-01-15', 'studyFirstSubmitQcDate': '2020-01-15', 'lastUpdatePostDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quantification of the difference in gene methylation in eosinophils from lean and obese subjects', 'timeFrame': 'baseline', 'description': 'Gene methylation of eosinophils will be quantified in samples derived from lean and obese fat biopsy'}], 'primaryOutcomes': [{'measure': 'Number of eosinophils in adipose tissue', 'timeFrame': 'baseline', 'description': 'eosinophil number will be measured by flow cytometry in subcutaneous (superficial) adipose tissue'}], 'secondaryOutcomes': [{'measure': 'Correlation between eosinophil content and body mass index (BMI)', 'timeFrame': 'baseline', 'description': 'Measured as a linear regression between BMI (defined as the weight in Kg/height in square m; kg/m2) and eosinophil number in the fat'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obese', 'Healthy']}, 'referencesModule': {'references': [{'pmid': '38206766', 'type': 'DERIVED', 'citation': 'Hernandez JD, Li T, Ghannam H, Rau CM, Masuda MY, Madura JA 2nd, Jacobsen EA, De Filippis E. Linking adipose tissue eosinophils, IL-4, and leptin in human obesity and insulin resistance. JCI Insight. 2024 Feb 8;9(3):e170772. doi: 10.1172/jci.insight.170772.'}], 'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Researchers are trying to better understand the relationship between inflammation in adipose tissue (AT) and insulin resistance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults ages 30-50 years\n* Non-smokers\n* Lean subjects with a BMI of 25 or less, gender specific normal body fat,\n* Obese, non-diabetic subjects with a BMI between 30 and 50 and taking no medications affecting glucose metabolism or lipid metabolism\n* subjects scheduled for an elective laparoscopic or laparotomy abdominal surgery\n\nExclusion Criteria:\n\n* Receiving corticosteroid therapy or have a history of asthma, COPD or atopic syndrome\n* taking any biologic treatment for any autoimmune disorder\n* Taking any leukotriene receptor antagonist acting medications (ex. Montelukast)\n* smoking'}, 'identificationModule': {'nctId': 'NCT04234295', 'briefTitle': 'Investigating the Effect of Obesity on Eosinophil Recruitment in Human Adipose Tissue', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Investigating the Effect of Obesity on Eosinophil Recruitment in Human Adipose Tissue', 'orgStudyIdInfo': {'id': '19-003803'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lean, Healthy Controls', 'description': 'Subjects with a body mass index (BMI) of 25 or less will have a fat tissue biopsy collected', 'interventionNames': ['Procedure: Fat Tissue Biopsy']}, {'type': 'EXPERIMENTAL', 'label': 'Obese, Non-Diabetic', 'description': 'Subject with a BMI between 30 and 50 kg/m2 will have fat tissue biopsy collected', 'interventionNames': ['Procedure: Fat Tissue Biopsy']}], 'interventions': [{'name': 'Fat Tissue Biopsy', 'type': 'PROCEDURE', 'description': 'If subjects are scheduled for a surgical procedure a fat sample will be collected during the beginning of the surgery. If subjects are not scheduled for a surgical procedure, a small sample of subcutaneous (superficial) fat tissue from subjects abdomen area will be collected.', 'armGroupLabels': ['Lean, Healthy Controls', 'Obese, Non-Diabetic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}], 'overallOfficials': [{'name': 'Elena De Filippis, 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': 'Elena Anna (Eleanna) De Filippis, M.D., Ph.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}