Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2026-04-14 @ 7:51 AM
Study NCT ID:
NCT02332603
Status:
COMPLETED
Last Update Posted:
2017-01-18
First Post:
2015-01-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Methylprednisolone on Glucose Homeostasis in Patients Undergoing Total Hip- and Knee-arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D008776', 'term': 'Methylprednisolone Hemisuccinate'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 134}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-17', 'studyFirstSubmitDate': '2015-01-05', 'studyFirstSubmitQcDate': '2015-01-06', 'lastUpdatePostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in plasma blood glucose from baseline (before surgery) to 48 hours after surgery', 'timeFrame': 'baseline to 48 hours'}], 'secondaryOutcomes': [{'measure': 'Changes in plasma C-peptide from baseline (before surgery) to 48 hours after surgery', 'timeFrame': 'baseline to 48 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Glucocorticoid', 'Glucose homeostasis', 'Knee arthroplasty, total', 'Hip arthroplasty, total'], 'conditions': ['Osteoarthrosis']}, 'referencesModule': {'references': [{'pmid': '23205862', 'type': 'BACKGROUND', 'citation': 'Husted H. Fast-track hip and knee arthroplasty: clinical and organizational aspects. Acta Orthop Suppl. 2012 Oct;83(346):1-39. doi: 10.3109/17453674.2012.700593.'}, {'pmid': '23663938', 'type': 'BACKGROUND', 'citation': 'Kehlet H. Fast-track hip and knee arthroplasty. Lancet. 2013 May 11;381(9878):1600-2. doi: 10.1016/S0140-6736(13)61003-X. No abstract available.'}, {'pmid': '24359028', 'type': 'BACKGROUND', 'citation': 'Khan SK, Malviya A, Muller SD, Carluke I, Partington PF, Emmerson KP, Reed MR. Reduced short-term complications and mortality following Enhanced Recovery primary hip and knee arthroplasty: results from 6,000 consecutive procedures. Acta Orthop. 2014 Feb;85(1):26-31. doi: 10.3109/17453674.2013.874925. Epub 2013 Dec 20.'}, {'pmid': '21895500', 'type': 'BACKGROUND', 'citation': 'Malviya A, Martin K, Harper I, Muller SD, Emmerson KP, Partington PF, Reed MR. Enhanced recovery program for hip and knee replacement reduces death rate. Acta Orthop. 2011 Oct;82(5):577-81. doi: 10.3109/17453674.2011.618911. Epub 2011 Sep 6.'}, {'pmid': '23558840', 'type': 'BACKGROUND', 'citation': 'Abdelmalak BB, Bonilla AM, Yang D, Chowdary HT, Gottlieb A, Lyden SP, Sessler DI. The hyperglycemic response to major noncardiac surgery and the added effect of steroid administration in patients with and without diabetes. Anesth Analg. 2013 May;116(5):1116-1122. doi: 10.1213/ANE.0b013e318288416d. Epub 2013 Apr 4.'}, {'pmid': '24299928', 'type': 'BACKGROUND', 'citation': 'Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear T, Vender JS, Gray J, Landry E. The effect of single low-dose dexamethasone on blood glucose concentrations in the perioperative period: a randomized, placebo-controlled investigation in gynecologic surgical patients. Anesth Analg. 2014 Jun;118(6):1204-12. doi: 10.1213/ANE.0b013e3182a53981.'}, {'pmid': '25115430', 'type': 'BACKGROUND', 'citation': 'de la Motte L, Kehlet H, Vogt K, Nielsen CH, Groenvall JB, Nielsen HB, Andersen A, Schroeder TV, Lonn L. Preoperative methylprednisolone enhances recovery after endovascular aortic repair: a randomized, double-blind, placebo-controlled clinical trial. Ann Surg. 2014 Sep;260(3):540-8; discussion 548-9. doi: 10.1097/SLA.0000000000000895.'}, {'pmid': '23117776', 'type': 'BACKGROUND', 'citation': 'Dieleman JM, Nierich AP, Rosseel PM, van der Maaten JM, Hofland J, Diephuis JC, Schepp RM, Boer C, Moons KG, van Herwerden LA, Tijssen JG, Numan SC, Kalkman CJ, van Dijk D; Dexamethasone for Cardiac Surgery (DECS) Study Group. Intraoperative high-dose dexamethasone for cardiac surgery: a randomized controlled trial. JAMA. 2012 Nov 7;308(17):1761-7. doi: 10.1001/jama.2012.14144.'}, {'pmid': '29944516', 'type': 'DERIVED', 'citation': 'Lindberg-Larsen V, Kehlet H, Bagger J, Madsbad S. Preoperative High-Dose Methylprednisolone and Glycemic Control Early After Total Hip and Knee Arthroplasty: A Randomized, Double-Blind, Placebo-Controlled Trial. Anesth Analg. 2018 Oct;127(4):906-913. doi: 10.1213/ANE.0000000000003591.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the pathophysiological effects of a single dose of Methylprednisolone administered prior to total hip- and knee-arthroplasty surgery. The investigators examine the effect on blood glucose homeostasis.\n\nHalf of participants will receive intravenous Solu-Medrol 125 mg, while the other half will receive placebo.\n\nThe investigators hypothesize that the glucose homeostasis remains equally stable in the group receiving Methylprednisolone as in the group receiving placebo.', 'detailedDescription': 'The anti-inflammatory effects of glucocorticoids are well known. The beneficial effects on postoperative pain, postoperative nausea and vomiting are well-documented.\n\nGlucocorticoid might change the glucose metabolism as it induces insulin-resistance. Glucocorticoids are known to reduce the insulin-mediated glucose uptake by reducing the muscle glycogen synthase activity.\n\nThe effect of a single high dose of glucocorticoid is poorly described in the literature, and therefore calls for further investigation.\n\nThis study is embedded in a primary study registrated as: NCT02319343\n\nFor further details please view the EudraCT registration:\n\nEudraCT nr.: 2014-003395-23'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Osteoarthrosis\n* Undergoing total unilateral hip- or knee arthroplasty surgery\n* Speak and understand Danish\n* Have given informed consent\n\nExclusion Criteria:\n\n* Revision or bilateral hip- or knee-arthroplasty surgery\n* General anaesthesia\n* Allergy or intolerance towards Methylprednisolone\n* Local or systemic infection\n* Permanent systemic treatment with steroids within 30 days preoperatively\n* Insulin-dependent diabetes\n* Active treatment of ulcer within 3 months preoperatively\n* Cancer disease\n* Autoimmune disease incl. rheumatoid arthritis\n* Pregnant or breast feeding women\n* Menopause \\<1 year'}, 'identificationModule': {'nctId': 'NCT02332603', 'briefTitle': 'Effect of Methylprednisolone on Glucose Homeostasis in Patients Undergoing Total Hip- and Knee-arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Effect of Preoperative Intravenous High Dose Methylprednisolone on Glucose Homeostasis in Patients Scheduled for Total Hip- and Knee-arthroplasty', 'orgStudyIdInfo': {'id': 'HK_VL_08_2014c'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Methylprednisolone', 'description': 'Preoperative single high dose of Solu-Medrol 125 mg iv.', 'interventionNames': ['Drug: Methylprednisolone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Isotonic Sodium Chloride', 'description': 'Preoperative single dose of isotonic Sodium Chloride', 'interventionNames': ['Drug: Isotonic Sodium Chloride']}], 'interventions': [{'name': 'Methylprednisolone', 'type': 'DRUG', 'otherNames': ['Solu-Medrol'], 'description': 'Comparison of preoperative single high dose of Methylprednisolone 125 mg iv. and isotonic Sodium Chloride', 'armGroupLabels': ['Methylprednisolone']}, {'name': 'Isotonic Sodium Chloride', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Isotonic Sodium Chloride']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen NV', 'country': 'Denmark', 'facility': 'Bispebjerg Hospital'}], 'overallOfficials': [{'name': 'Viktoria Lindberg-Larsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Section for Surgical Pathophysiology, Rigshospitalet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bispebjerg Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, research assistant', 'investigatorFullName': 'Viktoria Oline Lindberg-Larsen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}