Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:08 AM
Study NCT ID:
NCT01104220
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-23
First Post:
2010-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of Immune System in Obesity-related Inflammation and Cardiometabolic Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'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': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-22', 'studyFirstSubmitDate': '2010-04-13', 'studyFirstSubmitQcDate': '2010-04-14', 'lastUpdatePostDateStruct': {'date': '2025-10-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin sensitivity', 'timeFrame': 'Baseline', 'description': 'Insulin sensitivity assessed in vivo by using a hyperinsulinemic-euglycemic clamp procedure with stable isotope tracer infusion'}], 'secondaryOutcomes': [{'measure': 'TNF-alpha', 'timeFrame': 'Baseline', 'description': 'TNF-alpha is a marker of inflammation'}, {'measure': 'Interleukin-6 (IL-6)', 'timeFrame': 'Baseline', 'description': 'Interleukin-6 is a marker of inflammation'}, {'measure': 'Liver tissue inflammation', 'timeFrame': 'Baseline', 'description': 'Liver immune cell content'}, {'measure': 'Abdominal adipose tissue inflammation', 'timeFrame': 'Baseline only in participants scheduled for bariatric surgery', 'description': 'Subcutaneous, omental and transverse mesocolic adipose tissue'}, {'measure': 'Abdominal adipose tissue inflammation', 'timeFrame': 'Baseline only in participants scheduled for gallbladder, inguinal hernia, hysterectomy or myomectomy surgery', 'description': 'Subcutaneous and omental adipose tissue'}, {'measure': 'Upper vs lower adipose tissue inflammation', 'timeFrame': 'Baseline (All groups)', 'description': 'Immune cell content in abdominal and femoral subcutaneous adipose tissue'}, {'measure': 'Exosome-mediated intercellular signaling', 'timeFrame': 'Baseline only in participants scheduled for bariatric surgery', 'description': 'Signaling between cells and organs will be examined by isolating exosomes (small extracellular vesicles) from blood, subcutaneous, omental and transverse mesocolic adipose tissue and liver.'}, {'measure': 'Exosome-mediated intercellular signaling', 'timeFrame': 'Baseline only in participants scheduled for gallbladder, inguinal hernia, hysterectomy or myomectomy surgery', 'description': 'Signaling between cells and organs will be examined by isolating exosomes (small extracellular vesicles) from blood, subcutaneous and omental adipose tissue'}, {'measure': 'Exosome-mediated intercellular signaling', 'timeFrame': 'Baseline only in all participants', 'description': 'Signaling between cells and organs will be examined by isolating exosomes (small extracellular vesicles) from blood and abdominal and femoral subcutaneous adipose tissue.'}, {'measure': 'Change in exosome-mediated intercellular signaling', 'timeFrame': 'Before and after 20-30% weight loss (~3-4 months) in participants scheduled for bariatric surgery', 'description': 'Signaling between cells and organs will be examined by isolating exosomes (small extracellular vesicles) from blood and adipose tissue'}, {'measure': 'Hepatic PNPLA3 synthesis rate', 'timeFrame': 'Baseline only in people scheduled for gallbladder or bariatric surgery', 'description': 'Synthesis rates assessed by stable isotope techniques in the fasted vs the fed states'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NAFLD', 'Obesity', 'Metabolic syndrome'], 'conditions': ['Non-alcoholic Fatty Liver Disease', 'Metabolic Syndrome', 'Metabolically Abnormal Obesity', 'Metabolically Normal Obesity', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '31004409', 'type': 'RESULT', 'citation': 'Yoshino J, Patterson BW, Klein S. Adipose Tissue CTGF Expression is Associated with Adiposity and Insulin Resistance in Humans. Obesity (Silver Spring). 2019 Jun;27(6):957-962. doi: 10.1002/oby.22463. Epub 2019 Apr 19.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to learn more about how the body stores fat in and around organs (for example in the liver) and why this affects some people's health more than others. Understanding this may lead to better treatments for diseases such as diabetes and cardiovascular disease.", 'detailedDescription': 'The purpose of this study is to determine the specific cellular and organ system metabolic and immunologic alterations that are associated with insulin resistance and inflammation in order to identify putative mechanisms and novel bio-markers involved in the pathogenesis and progression of inflammatory and cardiometabolic diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nLean, metabolically healthy group - Body mass index (BMI) 18.5-24.9 kg/m2, HbA1C ≤5.6%, fasting plasma glucose concentration \\<100 mg/dl, 2-h OGTT plasma glucose concentration \\<140 mg/dl and intrahepatic triglyceride (IHTG) content ≤5%.\n\nObese, metabolically healthy group - BMI ≥30 kg/m2, HHbA1C ≤5.6%, fasting plasma glucose concentration \\<100 mg/dl, 2-h OGTT plasma glucose concentration \\<140 mg/dl and intrahepatic triglyceride (IHTG) content ≤5%.\n\nObese, metabolically healthy group - BMI ≥30 kg/m2, IHTG content ≥5.6% and HbA1C ≥5.7% or fasting plasma glucose concentration ≥100 mg/dl or 2-h OGTT plasma glucose concentration ≥140 mg/dl.\n\nLean, scheduled for inguinal hernia, hysterectomy or myomectomy surgery - BMI 18.5-24.9 kg/m2, HbA1C ≤5.6%, fasting plasma glucose concentration \\<100 mg/dl, 2-h OGTT plasma glucose concentration \\<140 mg/dl and IHTG content ≤5%.\n\nObese, scheduled for bariatric and gallbladder surgery - BMI ≥35.0kg/m2\n\nExclusion Criteria:\n\n* active or previous history of liver diseases other than NAFLD\n* history of alcohol abuse\n* currently consuming ≥20 g alcohol/day\n* severe hypertriglyceridemia (\\>300 mg/dL)\n* smoke tobacco\n* cancer diagnosis within the previous 5 years\n* medications that might confound the study results\n* pregnancy or lactation\n* exercise \\>2 h/week'}, 'identificationModule': {'nctId': 'NCT01104220', 'briefTitle': 'Role of Immune System in Obesity-related Inflammation and Cardiometabolic Risk', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Role of Immune System in Obesity-related Inflammation and Cardiometabolic Risk', 'orgStudyIdInfo': {'id': '201102127'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Lean, metabolically normal', 'description': 'Subjects with body mass index 18.5 - 24.9 kg/m² and normal fasting blood glucose and oral glucose tolerance and liver fat.'}, {'type': 'NO_INTERVENTION', 'label': 'Obese, metabolically normal', 'description': 'Subjects with body mass index ≥30.0 kg/m² and normal fasting blood glucose and oral glucose tolerance and liver fat.'}, {'type': 'NO_INTERVENTION', 'label': 'Obese, metabolically abnormal', 'description': 'Subjects with body mass index ≥30.0 kg/m² and impaired fasting or oral glucose tolerance and increased liver fat.'}, {'type': 'EXPERIMENTAL', 'label': 'Obese, scheduled for bariatric surgery', 'description': 'Subjects with a body mass index ≥35.0 kg/m² undergoing bariatric surgery', 'interventionNames': ['Other: Weight loss']}, {'type': 'NO_INTERVENTION', 'label': 'Obese, scheduled for gallbladder surgery', 'description': 'Subjects with a body mass index ≥35.0 kg/m² undergoing gallbladder surgery'}, {'type': 'NO_INTERVENTION', 'label': 'Lean, scheduled for inguinal hernia, hysterectomy or myomectomy surgery', 'description': 'Subjects with body mass index 18.5 - 24.9 kg/m² and normal fasting blood glucose and oral glucose tolerance and liver fat.'}], 'interventions': [{'name': 'Weight loss', 'type': 'OTHER', 'description': 'Bariatric surgery-induced weight loss to achieve \\~20%-30% reduction in initial body weight', 'armGroupLabels': ['Obese, scheduled for bariatric surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Samuel Klein, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}