Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT01229059
Status:
COMPLETED
Last Update Posted:
2023-08-15
First Post:
2010-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Free Fatty Acid Induced Insulin Resistance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D013024', 'term': 'Soybean Oil'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'muscle biopsies'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2019-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-11', 'studyFirstSubmitDate': '2010-03-20', 'studyFirstSubmitQcDate': '2010-10-26', 'lastUpdatePostDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intramyocellular lipid metabolites', 'timeFrame': 'after 4 hours lipid infusion', 'description': 'Muscle biopsies are taken before, after 2.5 and 4 hours of lipid infusion'}, {'measure': 'muscle glucose flux', 'timeFrame': 'during lipid infusion', 'description': 'glycogen synthesis rate, glucose-6-phosphate'}], 'secondaryOutcomes': [{'measure': 'insulin resistance of glucose uptake and mitochondrial function', 'timeFrame': 'after 4 hours lipid infusion', 'description': 'Mitochondrial function will bes assessed from muscle biopsy samples taken after 4 hours, insulin sensitivity will be assessed from hyperinsulinemic-euglycemic clamps following 4 hours lipid infusion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['FFA', 'insulin resistance', 'mitochondria'], 'conditions': ['Insulin Resistance']}, 'referencesModule': {'references': [{'pmid': '31672941', 'type': 'DERIVED', 'citation': 'Phielix E, Begovatz P, Gancheva S, Bierwagen A, Kornips E, Schaart G, Hesselink MKC, Schrauwen P, Roden M. Athletes feature greater rates of muscle glucose transport and glycogen synthesis during lipid infusion. JCI Insight. 2019 Nov 1;4(21):e127928. doi: 10.1172/jci.insight.127928.'}, {'pmid': '26423389', 'type': 'DERIVED', 'citation': 'Fritsch M, Koliaki C, Livingstone R, Phielix E, Bierwagen A, Meisinger M, Jelenik T, Strassburger K, Zimmermann S, Brockmann K, Wolff C, Hwang JH, Szendroedi J, Roden M. Time course of postprandial hepatic phosphorus metabolites in lean, obese, and type 2 diabetes patients. Am J Clin Nutr. 2015 Nov;102(5):1051-8. doi: 10.3945/ajcn.115.107599. Epub 2015 Sep 30.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to explore time-dependent effects of lipid infusion an intramyocellular lipid metabolites and the induction of impaired insulin signaling.', 'detailedDescription': 'Increased availability of free fatty acids impairs glucose disposal in young healthy humans. Patients with type 2 diabetes have reduced whole body glucose disposal, increased ectopic lipid deposition in skeletal muscle and the liver and impaired mitochondrial function. Recent studies suggest that lipid metabolites such as diacylglycerol (DAG), ceramides and long-chain acyl-coA represent the active mediators inducing insulin resistance. Possible targets are DAG-sensitive Proteinkinase C (PKC θ, PKC ε) which inhibit the insulin signaling cascade and ceramides which interfere with the insulin signaling cascade at Proteinkinase B/AKT. Prior studies raised controvesial evidence, thus, it is yet unclear, whether DAG or ceramides are the primary agents inducig lipid-induced insulin resistance. Therefore, the current study aims to explore the time course of the appearance of intramyocellular lipid compunds during lipid infusion in parallel assessing markers of impaired insulin action.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy, lean non-diabetic humans', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* non-diabetic (OGTT), no family history of diabetes, BMI\\<30 kg/m2, age: 20-55 years, no medication\n\nFor the athletes group additionally:\n\n* VO2max \\> 60ml/kg/min for males and VO2max \\> 45ml/kg/min for females Active in endurance-exercise activities, 3 times a week for at least 2 years Stable level of training for at least 3 months\n\nExclusion Criteria:\n\n* acute illness within the last 2 weeks, autoimmune diseases, renal insufficiency (creatinine\\> 1.5 mg/dl), cardiovascular diseases, anemia (Hb\\< 12g/l), donation of blood within the last 4 weeks before the study, thyroid diseases, pregnancy, smoking, night-shift working (disturbed circadian rhythm), defective coagulation or wound healing, cancer, allergy against soja products'}, 'identificationModule': {'nctId': 'NCT01229059', 'acronym': 'FFAIR', 'briefTitle': 'Free Fatty Acid Induced Insulin Resistance', 'organization': {'class': 'OTHER', 'fullName': 'German Diabetes Center'}, 'officialTitle': 'Assessment of the Time Course of Lipid Induced Insulin Resistance', 'orgStudyIdInfo': {'id': 'FFAIR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'lipid infusion in untrained humans', 'description': 'healthy lean humans before and after lipid infusion', 'interventionNames': ['Dietary Supplement: Lipovenös lipid infusion']}, {'label': 'lipid infusion in athletes', 'description': 'endurance trained atheletes', 'interventionNames': ['Dietary Supplement: Lipovenös lipid infusion']}], 'interventions': [{'name': 'Lipovenös lipid infusion', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['soy oil'], 'description': 'Lipid enriched infusions will be applied for 2-6 hours.', 'armGroupLabels': ['lipid infusion in athletes', 'lipid infusion in untrained humans']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40225', 'city': 'Düsseldorf', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'German Diabetes Center', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'overallOfficials': [{'name': 'Michael Roden, Prof., MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'German Diabetes Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'German Diabetes Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Heinrich-Heine University, Duesseldorf', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}