Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2026-03-01 @ 5:39 PM
Study NCT ID:
NCT01906333
Status:
COMPLETED
Last Update Posted:
2015-05-28
First Post:
2013-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Elevated FFA and Skeletal Muscle Lipid Content
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D005947', 'term': 'Glucose'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-27', 'studyFirstSubmitDate': '2013-07-16', 'studyFirstSubmitQcDate': '2013-07-19', 'lastUpdatePostDateStruct': {'date': '2015-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in IntraMyoCellularLipid (IMCL)content', 'timeFrame': 'Baseline, directly postexercise and 4 hours post-exercise', 'description': 'A muscle biopsy will be withdrawn before, after 2 hours of exercise and again 4 hours post-exercise for later analysis of IMCL.'}], 'secondaryOutcomes': [{'measure': 'Change in substrate metabolism', 'timeFrame': 'Measured several time points during the test day', 'description': 'Substrate metabolism will be measured for 15 min every 30 min of exercise and 20 min every hour of recovery for later analysis of fat- and glucose oxidation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Exercise', 'Ectopic fat accumulation'], 'conditions': ['Diabetes', 'Exercise Physiology']}, 'descriptionModule': {'briefSummary': 'There is increasing evidence that skeletal muscle lipid content (IntraMyoCellular Lipid, IMCL) markedly increases the risk of metabolic complications, including insulin resistance and cardiovascular events. The investigator hypothesizes that skeletal muscle is passively taking up FFAs when the availability is high, thereby leading to an increased storage. To test this hypothesis, the investigator wants to manipulate FFA levels, by means of exercise, and monitor intramuscular lipid content.\n\nTherefore the objective is to examine the effect of an exercise-induced elevation of FFA on skeletal muscle lipid content in healthy lean men. To this end, skeletal muscle lipid content will be investigated at baseline and after an exercise protocol and again after a four-hour recovery period from exercise, once in a condition with high FFA concentration, once with low FFA concentration. To achieve high- versus low FFA concentrations, an exercise protocol was chosen and participants had to perform this protocol once with a glucose supplementation and once without.\n\nSkeletal muscle lipid content will be determined before, directly after exercise and 4 h post exercise (from muscle biopsies) with or without glucose supplementation.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male sex\n* Age 18-30 years\n* Lean, BMI 18-25 kg/m2\n* Healthy\n* Stable dietary habits\n* No medication use\n\nExclusion Criteria:\n\n* Female sex\n* Engagement in programmed exercise \\> 2 hours total per week\n* Cardiac problems, such as angina pectoris, cardiac infarction and arrhythmias\n* First degree relatives with type 2 diabetes mellitus\n* Any medical condition requiring treatment and/or medication use\n* Unstable body weight (weight gain or loss \\> 3 kg in the past three months)\n* Participation in other biomedical study within 1 month prior to the screening visit\n* Subjetcs, who do not want to be informed about unexpected medical findings, or do not wish that their treating physician is informed, cannot participate in the study'}, 'identificationModule': {'nctId': 'NCT01906333', 'briefTitle': 'Elevated FFA and Skeletal Muscle Lipid Content', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Effects of Acute Elevation of Circulating Fatty Acids on Skeletal Muscle Lipid Accumulation and Metabolism in Healthy Lean Young Men', 'orgStudyIdInfo': {'id': 'NL43302.068.13/METC 13-3-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise & Glucose', 'description': '2 hour exercise while getting glucose-supplementation', 'interventionNames': ['Other: Exercise', 'Other: Glucose']}, {'type': 'EXPERIMENTAL', 'label': 'Exercise & Fasted', 'description': '2 hour exercise while staying fasted', 'interventionNames': ['Other: Exercise', 'Other: Fasted']}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'armGroupLabels': ['Exercise & Fasted', 'Exercise & Glucose']}, {'name': 'Glucose', 'type': 'OTHER', 'armGroupLabels': ['Exercise & Glucose']}, {'name': 'Fasted', 'type': 'OTHER', 'armGroupLabels': ['Exercise & Fasted']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Department of Human Biology, Maastricht University Medical Center (MUMC)', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD student', 'investigatorFullName': 'Lena Bilet', 'investigatorAffiliation': 'Maastricht University Medical Center'}}}}