Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2026-01-02 @ 3:13 AM
Study NCT ID:
NCT01423968
Status:
COMPLETED
Last Update Posted:
2018-03-27
First Post:
2011-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Lipopolysaccharide on Skeletal Muscle Functions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D004731', 'term': 'Endotoxins'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-23', 'studyFirstSubmitDate': '2011-08-11', 'studyFirstSubmitQcDate': '2011-08-25', 'lastUpdatePostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skeletal Muscle Protein Turnover (muscle tracer incorporation)', 'timeFrame': '4 hr following LPS infusion', 'description': 'incorporation of 1,2 13C-leucine into muscle tissue'}], 'secondaryOutcomes': [{'measure': 'Whole body glucose disposal', 'timeFrame': '4 h Glucose insulin clamp', 'description': 'Glucose uptake calculated from glucose infused to maintain euglycemia during a constant insulin infusion.'}, {'measure': 'Expression of genes that regulate muscle protein balance and insulin signalling', 'timeFrame': '4 h following LPS infusion', 'description': 'Changes in mRNA levels of several transcripts associated with metabolism or muscle growth in skeletal muscle'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sepsis', 'Inflammation', 'Lipopolysaccharide', 'Muscle protein turnover', 'Insulin resistance'], 'conditions': ['Sepsis']}, 'descriptionModule': {'briefSummary': 'The investigators aim to examine how the skeletal muscles of the human volunteers respond to experimental septic conditions to aid understanding of muscle wasting and its biology..\n\nSix healthy men aged 18-30 will be randomly assigned to two metabolic study visits. On the first visit, while resting on a bed, they will have four cannulae inserted including one in the upper thigh, for blood sampling and the infusion of insulin, glucose and normal and tracer amino acids (which allow us to measure muscle protein metabolism). Subjects will receive either injection of purified bacterial product called lipopolysaccharide (LPS) to induce flu-like symptoms or normal saline according to randomization followed by a metabolic test to stimulate muscle synthesis and glucose transport. Three small samples of muscle will be obtained under local anaesthetic from the thigh to measure molecular events in muscle. By performing these measurements, the investigators will determine the consequences of LPS on muscle production and carbohydrate metabolism.', 'detailedDescription': 'During sepsis, the ability of the body to prevent muscle wasting is impaired resulting in loss of skeletal muscle. In addition, skeletal muscle handling of carbohydrate becomes less efficient. These changes could result in delayed recovery, prolonged rehabilitation and in severe cases mortality of patients. It is still unclear how these changes occur in the human skeletal muscles but animal experiments suggest that protein molecules that are released during sepsis are responsible for these changes. Due to the biological differences between animals and humans in metabolic rate and stability, disease susceptibility and response to infection, simple translation of knowledge from animals to patients could be highly misleading. Therefore, we aim to examine how the skeletal muscles of the human volunteers respond to experimental septic conditions.\n\nFollowing medical screening, six healthy men aged 18-30 will have two metabolic study visits in a random manner. On the first visit, while resting on a bed, they will have four cannulae inserted including one in the upper thigh, for blood sampling and the infusion of insulin, glucose and normal and tracer amino acids (which allow us to measure muscle protein metabolism). Subjects will receive either injection of purified bacterial product called lipopolysaccharide (LPS) to induce flu-like symptoms or normal saline according to randomization followed by a metabolic test to stimulate muscle synthesis and glucose transport. Three small samples of muscle will be obtained under local anaesthetic from the thigh to measure molecular events in muscle. By performing these measurements, we will determine the consequences of LPS on muscle production and carbohydrate metabolism.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nMale 18-30yrs\n\nExclusion Criteria:\n\nClotting disorders Metabolic disease e.g. diabetes, thyroid dysfunction Inflammatory conditions e.g. Crohn's Disease Tobacco smoker Cardiac or Renal pathology Respiratory problems including Asthma Active infectious conditions"}, 'identificationModule': {'nctId': 'NCT01423968', 'acronym': 'LPS', 'briefTitle': 'Effect of Lipopolysaccharide on Skeletal Muscle Functions', 'organization': {'class': 'OTHER', 'fullName': 'University of Nottingham'}, 'officialTitle': 'Impact & Time-Course of Effect of Intravenous Lipopolysaccharide Infusion on Skeletal Muscle Protein Turnover and Insulin Sensitivity in Healthy Human Volunteers', 'orgStudyIdInfo': {'id': 'B/12/2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lipopolysaccharide infusion', 'description': 'Lipopolysaccharide infusion; dosage 4ng/kg body weight', 'interventionNames': ['Biological: Lipopolysaccharide infusion']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'saline', 'description': '0.9% saline infusion', 'interventionNames': ['Other: saline']}], 'interventions': [{'name': 'Lipopolysaccharide infusion', 'type': 'BIOLOGICAL', 'otherNames': ['Endotoxin'], 'description': 'Lipopolysaccharide 4 nanogram/kg body weight', 'armGroupLabels': ['Lipopolysaccharide infusion']}, {'name': 'saline', 'type': 'OTHER', 'otherNames': ['0.9% saline infusion'], 'armGroupLabels': ['saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG7 2UH', 'city': 'Nottingham', 'state': 'Nottinghamshire', 'country': 'United Kingdom', 'facility': 'Queens Medical Centre', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Paul L Greenhaff, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Muscle Metabolism, University of Nottingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nottingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Research Fellow', 'investigatorFullName': 'Elizabeth Simpson', 'investigatorAffiliation': 'University of Nottingham'}}}}