Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-02-20 @ 3:51 PM
Study NCT ID:
NCT01729156
Status:
COMPLETED
Last Update Posted:
2019-10-15
First Post:
2012-11-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Metformin on Hepatic FFA Metabolism
Sponsor:
Organization:
Raw JSON
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Gormsen, Consultant', 'organization': 'Department of Nuclear Medicine & PET Centre, Aarhus University Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'During the 90 days trial', 'eventGroups': [{'id': 'EG000', 'title': 'Healthy Controls', 'description': 'Healthy controls receiving 1000 mg metformin twice daily for 3 months\n\nMetformin: 1000 mg metformin twice daily in 3 months', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 1, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: 2 tablets twice daily in 3 months', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 1, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Metformin', 'description': 'Metformin "Teva", 1000 mg twice daily for 3 months\n\nMetformin: 1000 mg metformin twice daily in 3 months', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Gastrointestinal uncomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fractured vertebral column', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hepatic Fatty Acid Oxidation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Controls', 'description': 'Healthy controls receiving 1000 mg metformin twice daily for 3 months\n\nMetformin: 1000 mg metformin twice daily in 3 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: 2 tablets twice daily in 3 months'}, {'id': 'OG002', 'title': 'Metformin', 'description': 'Metformin "Teva", 1000 mg twice daily for 3 months\n\nMetformin: 1000 mg metformin twice daily in 3 months'}], 'classes': [{'categories': [{'measurements': [{'value': '0.052', 'spread': '0.024', 'groupId': 'OG000'}, {'value': '0.045', 'spread': '0.024', 'groupId': 'OG001'}, {'value': '0.042', 'spread': '0.017', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days', 'description': 'Hepatic fatty acid 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'0.035', 'groupId': 'OG001'}, {'value': '0.113', 'spread': '0.025', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days', 'description': 'Hepatic fatty acid reesterification assessed by C11-palmitate PET', 'unitOfMeasure': 'micromol/ml/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Hepatic Fatty Acid Uptake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Controls', 'description': 'Healthy controls receiving 1000 mg metformin twice daily for 3 months\n\nMetformin: 1000 mg metformin twice daily in 3 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: 2 tablets twice daily in 3 months'}, {'id': 'OG002', 'title': 'Metformin', 'description': 'Metformin "Teva", 1000 mg twice daily for 3 months\n\nMetformin: 1000 mg metformin twice daily in 3 months'}], 'classes': [{'categories': [{'measurements': [{'value': '0.186', 'spread': '0.067', 'groupId': 'OG000'}, {'value': '0.137', 'spread': '0.051', 'groupId': 'OG001'}, {'value': '0.155', 'spread': '0.029', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days', 'description': 'Hepatic fatty acid uptake assessed by C11-palmitate PET', 'unitOfMeasure': 'micromol/ml/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'VLDL-TG Secretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Controls', 'description': 'Healthy controls receiving 1000 mg metformin twice daily for 3 months\n\nMetformin: 1000 mg metformin twice daily in 3 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: 2 tablets twice daily in 3 months'}, {'id': 'OG002', 'title': 'Metformin', 'description': 'Metformin "Teva", 1000 mg twice daily for 3 months\n\nMetformin: 1000 mg metformin twice daily in 3 months'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'spread': '30', 'groupId': 'OG000'}, {'value': '83', 'spread': '49', 'groupId': 'OG001'}, {'value': '71', 'spread': '31', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days', 'description': 'Hepatic VLDL-TG secretion assessed by \\[1-14C\\] VLDL tracer', 'unitOfMeasure': 'micromol/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Whole Body Glucose Rd', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Controls', 'description': 'Healthy controls receiving 1000 mg metformin twice daily for 3 months\n\nMetformin: 1000 mg metformin twice daily in 3 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: 2 tablets twice daily in 3 months'}, {'id': 'OG002', 'title': 'Metformin', 'description': 'Metformin "Sandoz", 1000 mg twice daily for 3 months\n\nMetformin: 1000 mg metformin twice daily in 3 months'}], 'classes': [{'categories': [{'measurements': [{'value': '1.74', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '1.30', 'spread': '0.31', 'groupId': 'OG001'}, {'value': '1.78', 'spread': '0.43', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days', 'description': 'Whole body basal glucose metabolism assessed by \\[3-3H\\]glucose tracer kinetics', 'unitOfMeasure': 'mg/kg/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fatty Acid Turnover', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Controls', 'description': 'Healthy controls receiving 1000 mg metformin twice daily for 3 months\n\nMetformin: 1000 mg metformin twice daily in 3 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: 2 tablets twice daily in 3 months'}, {'id': 'OG002', 'title': 'Metformin', 'description': 'Metformin "Teva", 1000 mg twice daily for 3 months\n\nMetformin: 1000 mg metformin twice daily in 3 months'}], 'classes': [{'categories': [{'measurements': [{'value': '464', 'spread': '127', 'groupId': 'OG000'}, {'value': '476', 'spread': '149', 'groupId': 'OG001'}, {'value': '559', 'spread': '295', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days', 'description': 'Fatty acid turnover assessed as whole body C11-palmitate turnover', 'unitOfMeasure': 'micromol/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'VLDL-TG Oxidation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Controls', 'description': 'Healthy controls receiving 1000 mg metformin twice daily for 3 months\n\nMetformin: 1000 mg metformin twice daily in 3 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: 2 tablets twice daily in 3 months'}, {'id': 'OG002', 'title': 'Metformin', 'description': 'Metformin "Teva", 1000 mg twice daily for 3 months\n\nMetformin: 1000 mg metformin twice daily in 3 months'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'spread': '5', 'groupId': 'OG000'}, {'value': '30', 'spread': '7', 'groupId': 'OG001'}, {'value': '27', 'spread': '9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days', 'description': 'VLDL-TG oxidation assessed by 14C carbon dioxide (CO2) in exhaled breath', 'unitOfMeasure': 'percentage of 14C-VLDL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Controls', 'description': 'Healthy controls receiving 1000 mg metformin twice daily for 3 months\n\nMetformin: 1000 mg metformin twice daily in 3 months'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: 2 tablets twice daily in 3 months'}, {'id': 'FG002', 'title': 'Metformin', 'description': 'Metformin "Teva", 1000 mg twice daily for 3 months\n\nMetformin: 1000 mg metformin twice daily in 3 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Controls', 'description': 'Healthy controls receiving 1000 mg metformin twice daily for 3 months\n\nMetformin: 1000 mg metformin twice daily in 3 months'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: 2 tablets twice daily in 3 months'}, {'id': 'BG002', 'title': 'Metformin', 'description': 'Metformin "Teva", 1000 mg twice daily for 3 months\n\nMetformin: 1000 mg metformin twice daily in 3 months'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'spread': '6', 'groupId': 'BG000'}, {'value': '60', 'spread': '5', 'groupId': 'BG001'}, {'value': '64', 'spread': '5', 'groupId': 'BG002'}, {'value': '62', 'spread': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '27.3', 'spread': '4.1', 'groupId': 'BG000'}, {'value': '31.2', 'spread': '4.3', 'groupId': 'BG001'}, {'value': '30.3', 'spread': '5.7', 'groupId': 'BG002'}, {'value': '29.6', 'spread': '4.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HbA1C', 'classes': [{'categories': [{'measurements': [{'value': '37', 'spread': '3', 'groupId': 'BG000'}, {'value': '45', 'spread': '6', 'groupId': 'BG001'}, {'value': '51', 'spread': '6', 'groupId': 'BG002'}, {'value': '44', 'spread': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/mmol', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2013-02-04', 'size': 224998, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-09-24T09:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-24', 'studyFirstSubmitDate': '2012-11-13', 'resultsFirstSubmitDate': '2019-09-24', 'studyFirstSubmitQcDate': '2012-11-13', 'lastUpdatePostDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-24', 'studyFirstPostDateStruct': {'date': '2012-11-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hepatic Fatty Acid Oxidation', 'timeFrame': '90 days', 'description': 'Hepatic fatty acid oxidation assessed by dynamic C11-palmitate PET'}, {'measure': 'Hepatic Fatty Acid Reesterification', 'timeFrame': '90 days', 'description': 'Hepatic fatty acid reesterification assessed by C11-palmitate PET'}, {'measure': 'Hepatic Fatty Acid Uptake', 'timeFrame': '90 days', 'description': 'Hepatic fatty acid uptake assessed by C11-palmitate PET'}, {'measure': 'VLDL-TG Secretion', 'timeFrame': '90 days', 'description': 'Hepatic VLDL-TG secretion assessed by \\[1-14C\\] VLDL tracer'}, {'measure': 'Whole Body Glucose Rd', 'timeFrame': '90 days', 'description': 'Whole body basal glucose metabolism assessed by \\[3-3H\\]glucose tracer kinetics'}], 'secondaryOutcomes': [{'measure': 'Fatty Acid Turnover', 'timeFrame': '90 days', 'description': 'Fatty acid turnover assessed as whole body C11-palmitate turnover'}, {'measure': 'VLDL-TG Oxidation', 'timeFrame': '90 days', 'description': 'VLDL-TG oxidation assessed by 14C carbon dioxide (CO2) in exhaled breath'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Type 2 diabetes', 'Hepatic fatty acid oxidation', 'Dyslipidemia', 'Metformin'], 'conditions': ['Type 2 Diabetes', 'Dyslipidemia']}, 'referencesModule': {'references': [{'pmid': '30976851', 'type': 'DERIVED', 'citation': 'Gormsen LC, Sondergaard E, Christensen NL, Brosen K, Jessen N, Nielsen S. Metformin increases endogenous glucose production in non-diabetic individuals and individuals with recent-onset type 2 diabetes. Diabetologia. 2019 Jul;62(7):1251-1256. doi: 10.1007/s00125-019-4872-7. Epub 2019 Apr 11.'}]}, 'descriptionModule': {'briefSummary': 'Background: Metformin treatment has beneficial effects on both glucose and lipid metabolism. Whereas there is general agreement that the blood glucose lowering effect of metformin results from inhibition of hepatic gluconeogenesis, it is less clear exactly how the drug lowers blood triglyceride concentration. There are indications that it enhances hepatic free fatty acid (FFA) oxidation thus diminishing substrate for reesterification and resecretion as very-low-density-lipoprotein (VLDL) triglycerides (TG). However, the liver is not easily accessible for sampling in humans and data on the clinical effects of metformin in the liver are therefore lacking. This may change due to the increasing use of the positron emission tomography (PET) technique. Using PET isotopes (11C or 18F) coupled to either palmitate or a fatty acid analogue, it is possible to non-invasively measure hepatic fatty acid handling.\n\nAim: To determine how 3 months metformin treatment (1000 mg twice daily) affects hepatic lipid and glucose metabolism in patients with newly diagnosed type 2 diabetes.\n\nDesign: Randomized, placebo controlled, double-blind parallel study with patients receiving either metformin or placebo. A control group of BMI and age-matched non-diabetic individuals will receive metformin for 3 months.\n\nHypothesis: Metformin lowers VLDL-TG secretion and circulating triglycerides by increasing hepatic fatty acid oxidation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recently diagnosed type 2 diabetes\n* Age 50-70 years\n* BMI\\<40\n\nExclusion Criteria:\n\n* Insulin treatment\n* NASH (non alcoholic steatohepatitis)\n* Cancer\n* Anemia\n* HbA1C\\>8.5 %\n* Chronic or acute pancreatitis\n* Alcohol or medicine abuse\n* Allergy towards metformin\n* Claustrophobia\n* Severe obesity (weight \\>130 kilogram)'}, 'identificationModule': {'nctId': 'NCT01729156', 'briefTitle': 'Effects of Metformin on Hepatic FFA Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Effects of Metformin on Hepatic Free Fatty Acid Metabolism in Patients Diagnosed With Type 2 Diabetes: A C11 PET Study', 'orgStudyIdInfo': {'id': 'C11palmitatMetformin'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Healthy controls', 'description': 'Healthy controls receiving 1000 mg metformin twice daily for 3 months', 'interventionNames': ['Drug: Metformin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin', 'description': 'Metformin "Sandoz", 1000 mg twice daily for 3 months', 'interventionNames': ['Drug: Metformin']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Metformin "Sandoz" 500 mg'], 'description': '1000 mg metformin twice daily in 3 months', 'armGroupLabels': ['Healthy controls', 'Metformin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '2 tablets twice daily in 3 months', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Lars C Gormsen, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lars Christian Gormsen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior Registrar, MD PhD', 'investigatorFullName': 'Lars Christian Gormsen', 'investigatorAffiliation': 'Aarhus University Hospital'}}}}