Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-03-02 @ 8:05 AM
Study NCT ID:
NCT01736202
Status:
COMPLETED
Last Update Posted:
2023-08-25
First Post:
2012-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Effects of an Oral Fat Load on Skeletal Muscle and Hepatic Insulin Sensitivity
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-23', 'studyFirstSubmitDate': '2012-11-26', 'studyFirstSubmitQcDate': '2012-11-26', 'lastUpdatePostDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in rate of glucose disappearance (Rd)', 'timeFrame': '6 hours', 'description': 'Measurement of whole body insulin sensitivity in a hyperinsulinamic euglicamic clamp with deuterated glucose kinetics'}], 'secondaryOutcomes': [{'measure': 'Change in rate of hepatic endogenous glucose production (EGP)', 'timeFrame': '6 hours', 'description': 'Measurement of hepatic EGP in a hyperinsulinamic euglicamic clamp with deuterated glucose kinetics'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['oral fat', 'insulin sensitivity'], 'conditions': ['Insulin Sensitivity']}, 'referencesModule': {'references': [{'pmid': '34704121', 'type': 'DERIVED', 'citation': 'Sarabhai T, Koliaki C, Mastrototaro L, Kahl S, Pesta D, Apostolopoulou M, Wolkersdorfer M, Bonner AC, Bobrov P, Markgraf DF, Herder C, Roden M. Dietary palmitate and oleate differently modulate insulin sensitivity in human skeletal muscle. Diabetologia. 2022 Feb;65(2):301-314. doi: 10.1007/s00125-021-05596-z. Epub 2021 Oct 26.'}, {'pmid': '32434996', 'type': 'DERIVED', 'citation': 'Sarabhai T, Kahl S, Szendroedi J, Markgraf DF, Zaharia OP, Barosa C, Herder C, Wickrath F, Bobrov P, Hwang JH, Jones JG, Roden M. Monounsaturated fat rapidly induces hepatic gluconeogenesis and whole-body insulin resistance. JCI Insight. 2020 May 21;5(10):e134520. doi: 10.1172/jci.insight.134520.'}, {'pmid': '28112681', 'type': 'DERIVED', 'citation': 'Hernandez EA, Kahl S, Seelig A, Begovatz P, Irmler M, Kupriyanova Y, Nowotny B, Nowotny P, Herder C, Barosa C, Carvalho F, Rozman J, Neschen S, Jones JG, Beckers J, de Angelis MH, Roden M. Acute dietary fat intake initiates alterations in energy metabolism and insulin resistance. J Clin Invest. 2017 Feb 1;127(2):695-708. doi: 10.1172/JCI89444. Epub 2017 Jan 23.'}]}, 'descriptionModule': {'briefSummary': 'The development of type 2 diabetes is based on a combination of insulin resistance and beta cell dysfunction. In the last years, elevated FFA were recognized as a key players in the pathogenesis of insulin resistance and type 2 diabetes.\n\nThe study compares the acute effects of an oral lipid bolus on insulin sensitivity and hepatic glucose metabolism in healthy humans.', 'detailedDescription': 'A dysregulation of lipid metabolism with increased levels of free fatty acids (FFA) represents one key mechanism in the pathogenesis of insulin resistance, which contributes to the development of type 2 diabetes (T2D). In most cases, dyslipidemia is related to obesity and the metabolic syndrome. Not only skeletal muscle glucose uptake, but also hepatic glucose fluxes are altered in insulin resistant states. In obese and T2D subjects, rates of gluconeogenesis (GNG) are increased, but in obese normoglycemic subjects endogenous glucose production (EGP) remains constant because of downregulation of glycogenolysis (GL). However, in T2D subjects, both GNG and GL are elevated, contributing to fasting and postprandial hyperglycemia. Therefore, elevated GNG rates may represent an early event in the pathophysiology of insulin resistance and T2D.\n\nPreliminary studies of our institute show that intravenous lipid infusion with subsequent elevation of FFA results in increased GNG rates without alteration of EGP in lean, non-diabetic subjects. In another recent study we investigated the effects of an oral fat load on hepatic insulin sensitivity. As expected, we did not find any alterations in EGP; however, rates of GNG and GL have not been assessed.\n\nThe aim of this study is to analyze the effects of an oral fat load with transiently elevated levels of circulating lipids on hepatic glucose fluxes, especially GNG and GL, to elucidate the role of dietary fat in the induction of insulin resistance in healthy humans.\n\nIn this randomized, controlled cross-over study, effects of oral palm oil and canola oil ingestion will be investigated in young, healthy lean subjects. Hepatic glucose fluxes will be assessed by two independent methods, in vivo magnet resonance spectroscopy (MRS) and the deuterated water/acetaminophen method, which also allows for the determination of glycogen cycling rates. Furthermore, hepatic phosphorus metabolites and liver fat content will be monitored by MRS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy male and female subjects\n* age 20-40\n* BMI 20-25 kg/m2\n\nExclusion Criteria:\n\n* hyperlipidemia\n* smoking\n* pregnancy\n* allergy against paracetamol/palm oil/canola oil\n* contraindication for MRI investigations\n* anaemia\n* taking drugs influencing lipid or glucose metabolism, the immune system or antihypertensive treatment\n* M. Meulengracht\n* Hepatitis/HIV\n* chronic diseases'}, 'identificationModule': {'nctId': 'NCT01736202', 'acronym': 'FLAME', 'briefTitle': 'Acute Effects of an Oral Fat Load on Skeletal Muscle and Hepatic Insulin Sensitivity', 'organization': {'class': 'OTHER', 'fullName': 'German Diabetes Center'}, 'officialTitle': 'Acute Effects of an Oral Fat Load on Skeletal Muscle and Hepatic Insulin Sensitivity (FLAME-study)', 'orgStudyIdInfo': {'id': 'FLAME'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Palm oil orally', 'description': 'oral fat load', 'interventionNames': ['Biological: fat orally']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Canola oil orally', 'description': 'Oral fat load', 'interventionNames': ['Biological: fat orally']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Water orally', 'description': 'oral water administration as control', 'interventionNames': ['Biological: fat orally']}], 'interventions': [{'name': 'fat orally', 'type': 'BIOLOGICAL', 'otherNames': ['water orally'], 'description': 'Oral ingestion of palm oil or canola oil or water at timepoint zero', 'armGroupLabels': ['Canola oil orally', 'Palm oil orally', 'Water orally']}]}, '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': 'STUDY_DIRECTOR', 'affiliation': 'German Diabetes Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'German Diabetes Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Center for Diabetes Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}