Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 11:11 PM
Study NCT ID:
NCT00330967
Status:
COMPLETED
Last Update Posted:
2015-04-03
First Post:
2006-05-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Mechanisms of Insulin Resistance in Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C545823', 'term': 'soybean oil, phospholipid emulsion'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'charles.oh@va.gov', 'phone': '602-277-5551', 'title': 'Charles Oh', 'phoneExt': '1-5127', 'organization': 'Phoenix VA Health Care System'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': "The study's original Principal Investigator left the VA prior to the completion of data acquisition and no further subjects were enrolled. The data entered were analyzed based solely on study files in the system."}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Group 1', 'description': 'Systemic Intralipid infusion group\n\n20% Intralipid: lipid infusion', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2', 'description': 'Femoral Intralipid infusion group\n\n20% Intralipid: lipid infusion', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Edema', 'notes': 'Right lower extremity edema following muscle biopsy.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Insulin Signaling With Lipid Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 2', 'description': 'Femoral Intralipid infusion subjects\n\n20% Intralipid: lipid infusion'}], 'classes': [{'title': 'IRS-1 Basal', 'categories': [{'measurements': [{'value': '0.4334', 'spread': '0.2199', 'groupId': 'OG000'}]}]}, {'title': 'IRS-1 Basal Lipid', 'categories': [{'measurements': [{'value': '0.7276', 'spread': '0.0173', 'groupId': 'OG000'}]}]}, {'title': 'IRS-1 Insulin', 'categories': [{'measurements': [{'value': '0.5264', 'spread': '0.3810', 'groupId': 'OG000'}]}]}, {'title': 'IRS-1 Insulin Lipid', 'categories': [{'measurements': [{'value': '0.3534', 'spread': '0.1391', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 h', 'description': 'IRS-1 expression in response to femoral lipid infusion in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blot bands, normalized to a housekeeping protein, GAPDH, in control and treated groups.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Phos-p38 MAPK Expression With Femoral Lipid and Insulin Infusions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 2', 'description': 'Femoral Intralipid infusion group'}], 'classes': [{'title': 'Phos-p38 MAPK Basal', 'categories': [{'measurements': [{'value': '0.000394', 'spread': '0.000164', 'groupId': 'OG000'}]}]}, {'title': 'Phos-p38 MAPK Basal Lipid', 'categories': [{'measurements': [{'value': '0.001271', 'spread': '0.001013', 'groupId': 'OG000'}]}]}, {'title': 'Phos-p38 MAPK Insulin', 'categories': [{'measurements': [{'value': '0.000337', 'spread': '0.000140', 'groupId': 'OG000'}]}]}, {'title': 'Phos-p38 MAPK Insulin Lipid', 'categories': [{'measurements': [{'value': '0.000270', 'spread': '0.000049', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 h', 'description': 'Phosphorylation of p38 MAPK in response to femoral lipid and insulin infusions. phospho-p38 MAPK expression in response to femoral lipid infusion in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'p38 MAPK Expression With Femoral Lipid and Insulin Infusions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 2', 'description': 'Femoral Intralipid infusion group'}], 'classes': [{'title': 'p38 MAPK Basal', 'categories': [{'measurements': [{'value': '0.000455', 'spread': '0.0000088', 'groupId': 'OG000'}]}]}, {'title': 'p38 MAPK Basal Lipid', 'categories': [{'measurements': [{'value': '0.001291', 'spread': '0.0008', 'groupId': 'OG000'}]}]}, {'title': 'p38 MAPK Insulin', 'categories': [{'measurements': [{'value': '0.000502', 'spread': '0.000337', 'groupId': 'OG000'}]}]}, {'title': 'p38 MAPK Insulin Lipid', 'categories': [{'measurements': [{'value': '0.000377', 'spread': '0.0000903', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 h', 'description': 'p38 MAPK expression in response to femoral lipid and insulin infusions in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Phospho-ERK MAPK Expression With Femoral Lipid and Insulin Infusions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 2', 'description': 'Femoral Intralipid infusion group'}], 'classes': [{'title': 'Phos-ERK MAPK Basal', 'categories': [{'measurements': [{'value': '0.000091', 'spread': '0.0000378', 'groupId': 'OG000'}]}]}, {'title': 'Phos-ERK MAPK Basal Lipid', 'categories': [{'measurements': [{'value': '0.000108', 'spread': '0.0000366', 'groupId': 'OG000'}]}]}, {'title': 'Phos-ERK MAPK Insulin', 'categories': [{'measurements': [{'value': '0.000096', 'spread': '0.0000103', 'groupId': 'OG000'}]}]}, {'title': 'Phos-ERK MAPK Insulin Lipid', 'categories': [{'measurements': [{'value': '0.000092', 'spread': '0.0000070', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 h', 'description': 'Phosphorylation of ERK MAPK in response to femoral lipid and insulin infusions in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'ERK MAPK Expression With Femoral Lipid and Insulin Infusions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 2', 'description': 'Femoral Intralipid infusion group'}], 'classes': [{'title': 'ERK MAPK Basal', 'categories': [{'measurements': [{'value': '0.000103', 'spread': '0.0000722', 'groupId': 'OG000'}]}]}, {'title': 'ERK MAPK Basal Lipid', 'categories': [{'measurements': [{'value': '0.000158', 'spread': '0.0000826', 'groupId': 'OG000'}]}]}, {'title': 'ERK MAPK Insulin', 'categories': [{'measurements': [{'value': '0.000124', 'spread': '0.0000237', 'groupId': 'OG000'}]}]}, {'title': 'ERK MAPK Insulin Lipid', 'categories': [{'measurements': [{'value': '0.000114', 'spread': '0.0000017', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 h', 'description': 'ERK MAPK expression in response to femoral lipid and insulin infusions in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Phospho-JNK MAPK Expression With Femoral Lipid and Insulin Infusions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 2', 'description': 'Femoral Intralipid infusion group'}], 'classes': [{'title': 'Phos-JNK MAPK Basal', 'categories': [{'measurements': [{'value': '0.00401', 'spread': '0.002967', 'groupId': 'OG000'}]}]}, {'title': 'Phos-JNK MAPK Basal Lipid', 'categories': [{'measurements': [{'value': '0.005888', 'spread': '0.004952', 'groupId': 'OG000'}]}]}, {'title': 'Phos-JNK MAPK Insulin', 'categories': [{'measurements': [{'value': '0.003756', 'spread': '0.002537', 'groupId': 'OG000'}]}]}, {'title': 'Phos-JNK MAPK Insulin Lipid', 'categories': [{'measurements': [{'value': '0.00224', 'spread': '0.001161', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 h', 'description': 'Phosphorylation of JNK MAPK in response to femoral lipid and insulin infusions in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'JNK MAPK Expression With Femoral Lipid and Insulin Infusions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 2', 'description': 'Femoral Intralipid infusion group'}], 'classes': [{'title': 'JNK MAPK Basal', 'categories': [{'measurements': [{'value': '0.001364', 'spread': '0.00594', 'groupId': 'OG000'}]}]}, {'title': 'JNK MAPK Basal Lipid', 'categories': [{'measurements': [{'value': '0.002996', 'spread': '0.002837', 'groupId': 'OG000'}]}]}, {'title': 'JNK MAPK Insulin', 'categories': [{'measurements': [{'value': '0.002151', 'spread': '0.002032', 'groupId': 'OG000'}]}]}, {'title': 'JNK MAPK Insulin Lipid', 'categories': [{'measurements': [{'value': '0.001783', 'spread': '0.001883', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 h', 'description': 'JNK MAPK expression in response to femoral lipid and insulin infusions in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1', 'description': 'Systemic Intralipid infusion subjects\n\n20% Intralipid: lipid infusion'}, {'id': 'FG001', 'title': 'Group 2', 'description': 'Femoral arterial Intralipid infusion subjects\n\n20% Intralipid: lipid infusion'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1', 'description': 'Systemic Intralipid infusion subjects\n\n20% Intralipid: lipid infusion'}, {'id': 'BG001', 'title': 'Group 2', 'description': 'Femoral Intralipid infusion subjects\n\n20% Intralipid: lipid infusion'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'title': '<=18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Between 18 and 65 years', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.65', 'spread': '11.43', 'groupId': 'BG001'}, {'value': '47.65', 'spread': '11.43', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples, muscle biopsies'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-17', 'studyFirstSubmitDate': '2006-05-26', 'resultsFirstSubmitDate': '2015-01-22', 'studyFirstSubmitQcDate': '2006-05-26', 'lastUpdatePostDateStruct': {'date': '2015-04-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-03-04', 'studyFirstPostDateStruct': {'date': '2006-05-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin Signaling With Lipid Infusion', 'timeFrame': '4 h', 'description': 'IRS-1 expression in response to femoral lipid infusion in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blot bands, normalized to a housekeeping protein, GAPDH, in control and treated groups.'}, {'measure': 'Phos-p38 MAPK Expression With Femoral Lipid and Insulin Infusions', 'timeFrame': '4 h', 'description': 'Phosphorylation of p38 MAPK in response to femoral lipid and insulin infusions. phospho-p38 MAPK expression in response to femoral lipid infusion in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.'}, {'measure': 'p38 MAPK Expression With Femoral Lipid and Insulin Infusions', 'timeFrame': '4 h', 'description': 'p38 MAPK expression in response to femoral lipid and insulin infusions in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.'}, {'measure': 'Phospho-ERK MAPK Expression With Femoral Lipid and Insulin Infusions', 'timeFrame': '4 h', 'description': 'Phosphorylation of ERK MAPK in response to femoral lipid and insulin infusions in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.'}, {'measure': 'ERK MAPK Expression With Femoral Lipid and Insulin Infusions', 'timeFrame': '4 h', 'description': 'ERK MAPK expression in response to femoral lipid and insulin infusions in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.'}, {'measure': 'Phospho-JNK MAPK Expression With Femoral Lipid and Insulin Infusions', 'timeFrame': '4 h', 'description': 'Phosphorylation of JNK MAPK in response to femoral lipid and insulin infusions in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.'}, {'measure': 'JNK MAPK Expression With Femoral Lipid and Insulin Infusions', 'timeFrame': '4 h', 'description': 'JNK MAPK expression in response to femoral lipid and insulin infusions in skeletal muscle. Relative protein expression was calculated by densitometry analysis of Western blots, normalized to a housekeeping protein, GAPDH, of control and treated groups.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fat Emulsions, Intravenous', 'Free Fatty Acids', 'Glucose Clamp Technique', 'Inflammation', 'Insulin Resistance', 'Muscle, Skeletal', 'NF-Kappa B'], 'conditions': ['Inflammation', 'Insulin Resistance']}, 'descriptionModule': {'briefSummary': 'The Objectives of the study are to: (1)compare the inflammatory response and insulin resistance in skeletal muscles during a systemic infusion of lipid with that during a local infusion of lipid into the femoral artery. which would cause minimal or no systemic hyperlipidemia but local plasma free fatty acid (FFA) concentrations similar to those during the systemic lipid infusion, and (2) determine the inflammatory response and insulin resistance in skeletal muscle during an infusion of lipid into the femoral artery as described above after NF-KB inhibition by high dose salicylate treatment in humans.', 'detailedDescription': 'Insulin resistance in skeletal muscle is a characteristic abnormality in obesity and the metabolic syndrome and a major factor responsible for the development of type 2 diabetes. Although the mechanisms responsible for muscle insulin resistance are largely unclear, lipid oversupply is an important factor. Among numerous potential mechanisms whereby lipid oversupply may cause muscle insulin resistance, current evidence points towards inflammation as being critical. Recent studies in animals, however, indicate that the inflammatory response in skeletal muscles may require the presence of circulating pro-inflammatory factors suggesting that the inflammation induced insulin resistance in skeletal muscles may be a secondary event. More specifically, activation of Nuclear Factor-Kappa B(NF-kB), and inflammatory master switch that drives the production of numerous pro-inflammatory cytokines in fat and liver, has been implicated in causing insulin resistance in skeletal muscles by increasing circulating pro-inflammatory cytokines. In contrast, animal studies have found that activation of NF-KB directly in skeletal muscles has no or little effect on its insulin sensitivity but does produce other abnormalities such as increased proteasome activity. The study shall therefore be undertaken to determine to what extent lipid-induced inflammation and insulin resistance in skeletal muscles requires the presence of circulating proinflammatory factors in humans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'healthy subjects', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* two groups of 16 healthy subjects\n\nExclusion Criteria:\n\n* diabetes or impaired glucose tolerance\n* peripheral vascular disease\n* pulmonary disease\n* clinically significant hepatic or renal disease\n* triglycerides \\>200mg/dl\n* anemia\n* abnormal PT, PTT or INR\n* pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT00330967', 'briefTitle': 'Mechanisms of Insulin Resistance in Humans', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Mechanisms of Insulin Resistance in Humans', 'orgStudyIdInfo': {'id': 'ENDA-029-05F'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'healthy subjects', 'interventionNames': ['Drug: 20% Intralipid']}, {'label': 'Group 2', 'description': 'healthy subjects different from group 1', 'interventionNames': ['Drug: 20% Intralipid']}], 'interventions': [{'name': '20% Intralipid', 'type': 'DRUG', 'description': 'lipid infusion', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix VA Health Care System Carl T. Hayden VA Medical Center, Phoenix, AZ', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'Charles C Oh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Phoenix VA Health Care System Carl T. Hayden VA Medical Center, Phoenix, AZ'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}