Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-02-25 @ 5:51 PM
Study NCT ID:
NCT01173705
Status:
TERMINATED
Last Update Posted:
2017-01-20
First Post:
2010-07-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Factors Involved in Obesity-related Inflammation and Insulin Resistance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D007249', 'term': 'Inflammation'}], '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': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood, omentum biopsy, subcutaneous fat biopsy, muscle biopsy (abdominal wall)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-19', 'studyFirstSubmitDate': '2010-07-29', 'studyFirstSubmitQcDate': '2010-07-29', 'lastUpdatePostDateStruct': {'date': '2017-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Examine the relationship between omega-3 content and inflammatory and oxidative stress markers', 'timeFrame': '5 years', 'description': 'We will evaluate fatty acid composition in adipose tissues depots, blood monocytes, and skeletal muscle to examine the relationship between omega-e content and inflammatory and oxidative stress markers.'}], 'secondaryOutcomes': [{'measure': 'Evaluate nutrient intake', 'timeFrame': '5 years', 'description': 'Using the NHANES Food Questionnaire, we will evaluate nutrient intakes of lean and obese individuals'}, {'measure': 'Compare effects of omega-3 and saturated fatty acid supplementation on inflammatory and oxidative stress markers (in vitro)', 'timeFrame': '5 years', 'description': 'Compare the effects of omega-3 and saturated FA supplementation on inflammatory and oxidative stress markers in vitro in adipose tissue explants, preadipocytes and monocyte culture.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity', 'Insulin Resistance', 'Inflammation'], 'conditions': ['Obesity', 'Insulin Resistance', 'Inflammation']}, 'descriptionModule': {'briefSummary': 'In this project, we propose to recruit lean and obese subjects with different ethnic background (African Americans and Caucasians) to study the alterations of lipid and carbohydrate metabolism and determine whether these disturbances are linked to genetic, inflammatory, oxidative stress, and/or nutritional factors. Because systemic inflammation and insulin resistance are frequent features of obesity, we postulate that an unbalanced diet with high saturated- and low omega 3-fatty acids is linked to obesity-related inflammation and insulin resistance. We propose to investigate fatty acid metabolism and determine the links between fatty acid composition and oxidative stress in tissues of lean and obese subjects. We propose the following aims:\n\nSpecific Aim 1: Evaluate nutrient intake in lean and obese subjects using the standard NHANES Food Questionnaire.\n\nSpecific Aim 2: Evaluate the fatty acid composition, including omega-3, in adipose tissue depots, blood monocytes and skeletal muscle, and examine the relationship between omega-3 content and inflammatory and oxidative stress markers.\n\nSpecific Aim 3: Compare the effects of omega-3 and saturated FA supplementation on inflammatory and oxidative stress markers in vitro in adipose tissue explants, preadipocytes and monocyte culture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Normal weight and obese subjects who are undergoing elective bariatric or abdominal surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-65 years of age\n* Undergoing elective abdominal or bariatric surgery\n\nExclusion Criteria:\n\n* Intercurrent infections\n* Active cancer diagnosis within 5 years\n* Use of medications for diabetes or hyperlipidemia\n* Use of glucocorticoids or anti-inflammatory drugs'}, 'identificationModule': {'nctId': 'NCT01173705', 'briefTitle': 'Factors Involved in Obesity-related Inflammation and Insulin Resistance', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Genetic and Nutritional Factors Involved in Obesity-related Inflammation and Insulin Resistance', 'orgStudyIdInfo': {'id': 'IRB #100919'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal weight: abdominal surgery', 'description': 'Lean individuals undergoing elective abdominal surgery'}, {'label': 'Obese: abdominal or bariatic surgery', 'description': 'Obese subjects undergoing elective abdominal or bariatric surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Robyn Tamboli, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}, {'name': 'Naji N Abumrad, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant Professor', 'investigatorFullName': 'Robyn Tamboli', 'investigatorAffiliation': 'Vanderbilt University'}}}}