Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2026-01-17 @ 12:12 AM
Study NCT ID:
NCT01686568
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2012-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Omega-3 Fatty Acids and Insulin Sensitivity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'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': 'D004281', 'term': 'Docosahexaenoic Acids'}, {'id': 'D005228', 'term': 'Fatty Acids, Essential'}, {'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'C405603', 'term': 'Omacor'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lanza.ian@mayo.edu', 'phone': '507-255-8147', 'title': 'Dr. Ian R. Lanza', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Omega-3', 'description': 'Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Patients in this group will be supplemented with placebo capsules containing ethyl oleate.', 'otherNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Insulin Sensitivity by Hyperinsulinemic-euglycemic Clamp at Baseline and 6 Month Follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omega-3', 'description': 'Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients in this group will be supplemented with placebo capsules containing ethyl oleate.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '10.92', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '10.39', 'spread': '0.76', 'groupId': 'OG001'}]}]}, {'title': '6 Month Follow Up', 'categories': [{'measurements': [{'value': '10.16', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '10.80', 'spread': '0.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, after 6 months of treatment', 'description': 'A 2-stage insulin clamp will be performed with titration of dextrose to maintain euglycemia. D2 glucose will be infused to evaluate hepatic glucose production at baseline and in response to insulin. Hyperinsulinemic-euglycemic clamp technique: The plasma insulin concentration is acutely raised and maintained by a continuous infusion of insulin. Meanwhile, the plasma glucose concentration is held constant at basal levels by a variable glucose infusion. When the steady-state is achieved, the glucose infusion rate (GIR) equals glucose uptake by all the tissues in the body and is therefore a measure of tissue insulin sensitivity.', 'unitOfMeasure': 'mg/kg FFM/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Beta Cell Function From Insulin Secretion Following Ingestion of a Mixed Meal at Baseline and 6 Month Follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omega-3', 'description': 'Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients in this group will be supplemented with placebo capsules containing ethyl oleate.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '537.17', 'spread': '45.33', 'groupId': 'OG000'}, {'value': '488.90', 'spread': '45.47', 'groupId': 'OG001'}]}]}, {'title': '6 Month Follow Up', 'categories': [{'measurements': [{'value': '561.33', 'spread': '48.21', 'groupId': 'OG000'}, {'value': '504.39', 'spread': '35.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, after 6 months of treatment', 'description': 'Following consumption of a mixed meal, beta cell function will be evaluated from serial measurements of C-peptide. C-peptide was measured using a two-side immunometric assay using electrochemiluminescence detection.', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mitochondrial Function Determined by Muscle Biopsy at Baseline and 6 Month Follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omega-3', 'description': 'Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients in this group will be supplemented with placebo capsules containing ethyl oleate.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '496.81', 'spread': '26.54', 'groupId': 'OG000'}, {'value': '564.86', 'spread': '42.10', 'groupId': 'OG001'}]}]}, {'title': '6 Month Follow Up', 'categories': [{'measurements': [{'value': '406.38', 'spread': '40.39', 'groupId': 'OG000'}, {'value': '495.12', 'spread': '39.79', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, after 6 months of treatment', 'description': 'Measurements of oxygen consumption in isolated mitochondria will be performed using a polarographic oxygen electrode.', 'unitOfMeasure': 'pmol/s/mg tissue', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Insulin Concentration Needed to Suppress Palmitate Appearance Rates (IC50(Palmitate)f)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omega-3', 'description': 'Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients in this group will be supplemented with placebo capsules containing ethyl oleate.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '24'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '22', 'upperLimit': '33'}]}]}, {'title': 'Post-intervention', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '29'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '46'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'approximately after 6 months of treatment', 'description': 'Sensitivity of adipose tissue lipolysis to insulin suppression, was calculated as the insulin concentration needed to suppress palmitate appearance rates (ie, flux) by 50% (IC50(palmitate)f).', 'unitOfMeasure': 'µU/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of subjects analyzed for this outcome measure for the placebo arm was 8 instead of 9. One subject did not have blood drawn for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Senescent Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omega-3', 'description': 'Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients in this group will be supplemented with placebo capsules containing ethyl oleate.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4', 'spread': '3', 'groupId': 'OG000'}, {'value': '4', 'spread': '3', 'groupId': 'OG001'}]}]}, {'title': 'Post-intervention', 'categories': [{'measurements': [{'value': '4', 'spread': '3', 'groupId': 'OG000'}, {'value': '4', 'spread': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'approximately after 6 months of treatment', 'description': 'Tissue burden of senescent cells, which was measured by staining for senescence-associated B-galactosidase activity and expressed as the number per 100 nucleated positive cells.', 'unitOfMeasure': 'number positive cells/100 total cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Immunohistochemistry Assessments of Macrophage Burden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omega-3', 'description': 'Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients in this group will be supplemented with placebo capsules containing ethyl oleate.'}], 'classes': [{'title': 'Total (CD68) baseline', 'categories': [{'measurements': [{'value': '31', 'spread': '8', 'groupId': 'OG000'}, {'value': '33', 'spread': '5', 'groupId': 'OG001'}]}]}, {'title': 'Total (CD68) post intervention', 'categories': [{'measurements': [{'value': '33', 'spread': '8', 'groupId': 'OG000'}, {'value': '31', 'spread': '5', 'groupId': 'OG001'}]}]}, {'title': 'M1 (CD14) baseline', 'categories': [{'measurements': [{'value': '11', 'spread': '6', 'groupId': 'OG000'}, {'value': '13', 'spread': '4', 'groupId': 'OG001'}]}]}, {'title': 'M1 (CD14) post intervention', 'categories': [{'measurements': [{'value': '14', 'spread': '6', 'groupId': 'OG000'}, {'value': '12', 'spread': '5', 'groupId': 'OG001'}]}]}, {'title': 'M2 (CD206) baseline', 'categories': [{'measurements': [{'value': '28', 'spread': '5', 'groupId': 'OG000'}, {'value': '29', 'spread': '7', 'groupId': 'OG001'}]}]}, {'title': 'M2 (CD206) post intervention', 'categories': [{'measurements': [{'value': '29', 'spread': '9', 'groupId': 'OG000'}, {'value': '29', 'spread': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'approximately after 6 months of treatment', 'description': 'One week after the pancreatic clamp study, participants were provided a standardized meal before an overnight fast. The next morning an abdominal adipose tissue biopsy was collected, and the samples were analyzed for adipocyte size. Immunohistochemistry was used to assess macrophage burden (total (CD68), M1 (CD14) and M2 (CD206) macrophages per 100 adipocytes).', 'unitOfMeasure': 'macrophages per 100 adipocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Macrophage Crown-like Structures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omega-3', 'description': 'Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients in this group will be supplemented with placebo capsules containing ethyl oleate.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3'}]}]}, {'title': 'Post-intervention', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'approximately after 6 months of treatment', 'description': 'Macrophages surrounding dying or dead adipocytes form crown-like structures (CLSs). One week after the pancreatic clamp study, participants were provided a standardized meal before an overnight fast. The next morning an abdominal adipose tissue biopsy was collected, and the samples were analyzed for adipocyte size. Immunohistochemistry was used to assess the number of crown-like structures per 10 images.', 'unitOfMeasure': 'crown-like structures per 10 images', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'EPA and DHA Concentrations in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omega-3', 'description': 'Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients in this group will be supplemented with placebo capsules containing ethyl oleate.'}], 'classes': [{'title': 'EPA Baseline', 'categories': [{'measurements': [{'value': '0.95', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.27', 'groupId': 'OG001'}]}]}, {'title': 'EPA Post-Intervention', 'categories': [{'measurements': [{'value': '6.0', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'DHA Baseline', 'categories': [{'measurements': [{'value': '0.89', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.39', 'groupId': 'OG001'}]}]}, {'title': 'DHA Post-Intervention', 'categories': [{'measurements': [{'value': '3.5', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '0.90', 'spread': '0.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'approximately after 6 months of treatment', 'description': 'Post hoc analyses were conducted to test whether EPA and DHA concentrations in plasma in response to intervention explained variation in outcome measures of adipose tissue lipolysis insulin sensitivity and inflammatory markers post-intervention.', 'unitOfMeasure': 'percentage of total free fatty acid', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'EPA and DHA Concentrations in Adipose Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omega-3', 'description': 'Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients in this group will be supplemented with placebo capsules containing ethyl oleate.'}], 'classes': [{'title': 'EPA baseline', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.01', 'groupId': 'OG001'}]}]}, {'title': 'EPA Post-Intervention', 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.01', 'groupId': 'OG001'}]}]}, {'title': 'DHA Baseline', 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '0.01', 'groupId': 'OG001'}]}]}, {'title': 'DHA Post-Intervention', 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'approximately after 6 months of treatment', 'description': 'Post hoc analyses were conducted to test whether EPA and DHA concentrations in subcutaneous abdominal adipose tissue in response to intervention explained variation in outcome measures of adipose tissue lipolysis insulin sensitivity and inflammatory markers post-intervention.', 'unitOfMeasure': 'percentage of total free fatty acid', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Omega-3', 'description': 'Patients in this group will receive oral supplementation with EPA + Docosahexaenoic acid (DHA) (3.9grams/day) for 6 months.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Patients in this group will be supplemented with placebo capsules containing ethyl oleate.'}], 'periods': [{'title': 'Main Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Noncompliance with protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Liver enzymes above range of exclusion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Sub-Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Not consented for sub-study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants were recruited from the Mayo Clinic in Rochester, Minnesota.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Omega-3', 'description': 'Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Patients in this group will be supplemented with placebo capsules containing ethyl oleate.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.3', 'spread': '2.9', 'groupId': 'BG000'}, {'value': '32.6', 'spread': '2.5', 'groupId': 'BG001'}, {'value': '34.1', 'spread': '9.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline characteristics were reported for participants who received treatment and did not withdraw from the study.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2015-06-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-18', 'studyFirstSubmitDate': '2012-09-11', 'resultsFirstSubmitDate': '2015-06-16', 'studyFirstSubmitQcDate': '2012-09-17', 'lastUpdatePostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-06-16', 'studyFirstPostDateStruct': {'date': '2012-09-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin Sensitivity by Hyperinsulinemic-euglycemic Clamp at Baseline and 6 Month Follow up', 'timeFrame': 'Baseline, after 6 months of treatment', 'description': 'A 2-stage insulin clamp will be performed with titration of dextrose to maintain euglycemia. D2 glucose will be infused to evaluate hepatic glucose production at baseline and in response to insulin. Hyperinsulinemic-euglycemic clamp technique: The plasma insulin concentration is acutely raised and maintained by a continuous infusion of insulin. Meanwhile, the plasma glucose concentration is held constant at basal levels by a variable glucose infusion. When the steady-state is achieved, the glucose infusion rate (GIR) equals glucose uptake by all the tissues in the body and is therefore a measure of tissue insulin sensitivity.'}], 'secondaryOutcomes': [{'measure': 'Beta Cell Function From Insulin Secretion Following Ingestion of a Mixed Meal at Baseline and 6 Month Follow up', 'timeFrame': 'baseline, after 6 months of treatment', 'description': 'Following consumption of a mixed meal, beta cell function will be evaluated from serial measurements of C-peptide. C-peptide was measured using a two-side immunometric assay using electrochemiluminescence detection.'}, {'measure': 'Mitochondrial Function Determined by Muscle Biopsy at Baseline and 6 Month Follow up', 'timeFrame': 'Baseline, after 6 months of treatment', 'description': 'Measurements of oxygen consumption in isolated mitochondria will be performed using a polarographic oxygen electrode.'}, {'measure': 'Insulin Concentration Needed to Suppress Palmitate Appearance Rates (IC50(Palmitate)f)', 'timeFrame': 'approximately after 6 months of treatment', 'description': 'Sensitivity of adipose tissue lipolysis to insulin suppression, was calculated as the insulin concentration needed to suppress palmitate appearance rates (ie, flux) by 50% (IC50(palmitate)f).'}, {'measure': 'Senescent Cells', 'timeFrame': 'approximately after 6 months of treatment', 'description': 'Tissue burden of senescent cells, which was measured by staining for senescence-associated B-galactosidase activity and expressed as the number per 100 nucleated positive cells.'}, {'measure': 'Immunohistochemistry Assessments of Macrophage Burden', 'timeFrame': 'approximately after 6 months of treatment', 'description': 'One week after the pancreatic clamp study, participants were provided a standardized meal before an overnight fast. The next morning an abdominal adipose tissue biopsy was collected, and the samples were analyzed for adipocyte size. Immunohistochemistry was used to assess macrophage burden (total (CD68), M1 (CD14) and M2 (CD206) macrophages per 100 adipocytes).'}, {'measure': 'Macrophage Crown-like Structures', 'timeFrame': 'approximately after 6 months of treatment', 'description': 'Macrophages surrounding dying or dead adipocytes form crown-like structures (CLSs). One week after the pancreatic clamp study, participants were provided a standardized meal before an overnight fast. The next morning an abdominal adipose tissue biopsy was collected, and the samples were analyzed for adipocyte size. Immunohistochemistry was used to assess the number of crown-like structures per 10 images.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Insulin Resistance']}, 'referencesModule': {'references': [{'pmid': '25852206', 'type': 'RESULT', 'citation': 'Lalia AZ, Johnson ML, Jensen MD, Hames KC, Port JD, Lanza IR. Effects of Dietary n-3 Fatty Acids on Hepatic and Peripheral Insulin Sensitivity in Insulin-Resistant Humans. Diabetes Care. 2015 Jul;38(7):1228-37. doi: 10.2337/dc14-3101. Epub 2015 Apr 7.'}, {'pmid': '28424185', 'type': 'DERIVED', 'citation': 'Hames KC, Morgan-Bathke M, Harteneck DA, Zhou L, Port JD, Lanza IR, Jensen MD. Very-long-chain omega-3 fatty acid supplements and adipose tissue functions: a randomized controlled trial. Am J Clin Nutr. 2017 Jun;105(6):1552-1558. doi: 10.3945/ajcn.116.148114. Epub 2017 Apr 19.'}]}, 'descriptionModule': {'briefSummary': 'This study is being done to understand the effects of dietary omega-3 fats on insulin sensitivity in adult men and women.', 'detailedDescription': 'Dietary omega-3 polyunsaturated fatty acids (n-3 PUFA), which include eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) from fish oil, prevent insulin resistance in rodents, but data in humans is ambiguous. No existing studies have systematically evaluated the influence of n-3 PUFAs on insulin sensitivity and beta cell function in insulin resistant, non-diabetic humans. The Investigators hypothesize that 6 months of oral supplementation of purified EPA/DHA (3.9g/day) will significantly improve hepatic and peripheral insulin sensitivity and beta cell responsiveness in insulin-resistant, non-diabetic individuals. Based on recent work in mice, the investigators also hypothesize that EPA/DHA will increase the content and function of mitochondria in skeletal muscle, measured using a combination of in vivo and in vitro methods. Overall, the investigators hypothesize that EPA+DHA supplementation will improve hepatic and peripheral insulin sensitivity in insulin resistant humans, and this improvement will be associated with mitochondrial biogenesis and attenuated lipid accumulation in skeletal muscle and liver.\n\nA sub-study was added in which participants receiving dietary omega-3 fatty acids or placebo supplements underwent abdominal subcutaneous adipose tissue biopsies to measure the content of total, pro- (M1) and anti- (M2) inflammatory macrophages (immunohistochemistry), crown-like structures (immunohistochemistry), and senescent cells (β-galactosidase staining), as well as a two-step euglycemic, pancreatic clamp with a stable-isotope labeled precursor ((U-13C)palmitate) infusion to determine the insulin concentration needed to suppress palmitate flux by 50% (IC50(palmitate)f).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Age 18-65 years\n2. Insulin resistant (Homeostasis Model Assessment (HOMA) Insulin Resistance (IR) ≥2.6)\n\nExclusion criteria:\n\n1. Current use of omega-3 nutritional supplements\n2. Fasting plasma glucose ≥126 mg/dL\n3. Active coronary artery disease\n4. Participation in structured exercise (\\>2 times per week for 30 minutes or longer)\n5. Smoking\n6. Medications known to affect muscle metabolism (e.g., beta blockers, corticosteroids, tricyclic-antidepressants, benzodiazepines, opiates, barbiturates, anticoagulants)\n7. Renal failure (serum creatinine \\> 1.5mg/dl)\n8. Chronic active liver disease (AST\\>144 IU/L and alanine transaminase (ALT)\\>165 IU/L)\n9. Anti-coagulant therapy (warfarin/heparin)\n10. International normalized ratio (INR) \\>3\n11. Use of systemic glucocorticoids\n12. Chronic use of NSAIDS or aspirin\n13. Pregnancy or breastfeeding\n14. Alcohol consumption greater than 2 glasses/day\n15. Hypothyroidism\n16. Fish or shellfish allergy'}, 'identificationModule': {'nctId': 'NCT01686568', 'briefTitle': 'Omega-3 Fatty Acids and Insulin Sensitivity', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Dietary Omega-3 Fatty Acids as a Therapeutic Strategy in Insulin Resistant Humans', 'orgStudyIdInfo': {'id': '12-004590'}, 'secondaryIdInfos': [{'id': 'KL2TR000136', 'link': 'https://reporter.nih.gov/quickSearch/KL2TR000136', 'type': 'NIH'}, {'id': 'U24DK100469', 'link': 'https://reporter.nih.gov/quickSearch/U24DK100469', 'type': 'NIH'}, {'id': 'DK50456', 'type': 'OTHER_GRANT', 'domain': 'Minnesota Obesity Center'}, {'id': 'DK40484', 'type': 'OTHER_GRANT', 'domain': 'Minnesota Obesity Center'}, {'id': '5T32DK007352', 'link': 'https://reporter.nih.gov/quickSearch/5T32DK007352', 'type': 'NIH'}, {'id': '5UL1TR000135', 'link': 'https://reporter.nih.gov/quickSearch/5UL1TR000135', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Omega-3', 'description': 'Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.', 'interventionNames': ['Drug: Omega-3']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients in this group will be supplemented with placebo capsules containing ethyl oleate.', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Omega-3', 'type': 'DRUG', 'otherNames': ['Essential fatty acids', 'Omega-3 fatty acids', 'Omega-3 polyunsaturated fatty acids', 'PUFAs', 'Lovaza'], 'description': 'Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.', 'armGroupLabels': ['Omega-3']}, {'name': 'placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Ian Lanza, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Advancing Translational Sciences (NCATS)', 'class': 'NIH'}, {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': "Building Interdisciplinary Research Careers in Women's Health", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Ian R. Lanza', 'investigatorAffiliation': 'Mayo Clinic'}}}}