Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-29 @ 6:54 AM
Study NCT ID:
NCT06107959
Status:
RECRUITING
Last Update Posted:
2025-07-11
First Post:
2023-10-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes in Resting Metabolic Rate Following Orthopedic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Urine Specific Gravity, hydration assessment in order to complete the body composition test.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-08', 'studyFirstSubmitDate': '2023-10-12', 'studyFirstSubmitQcDate': '2023-10-24', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the magnitude of the change in RMR of patients receiving orthopedic surgery.', 'timeFrame': '12 weeks', 'description': 'RMR = (9.99 X actual weight\\*)+ (6.25 X height\\*) - (4.92 X age) - 161\\*use weight in kilograms (kilogram), height in centimeters (cm).'}, {'measure': 'To observe the amount of time it takes the RMR to return to baseline.', 'timeFrame': '12 weeks', 'description': 'calculation in number of weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Metabolism; Disorder, Postprocedural', 'Resting Metabolic Rate', 'Post Operative Nutrition']}, 'referencesModule': {'references': [{'pmid': '3283387', 'type': 'BACKGROUND', 'citation': 'Braga M, Baccari P, Scaccabarozzi S, Fiacco E, Radaelli G, Gallus G, DiPalo S, DiCarlo V, Cristallo M. Prognostic role of preoperative nutritional and immunological assessment in the surgical patient. JPEN J Parenter Enteral Nutr. 1988 Mar-Apr;12(2):138-42. doi: 10.1177/0148607188012002138.'}, {'pmid': '9654632', 'type': 'BACKGROUND', 'citation': 'Hu SS, Fontaine F, Kelly B, Bradford DS. Nutritional depletion in staged spinal reconstructive surgery. The effect of total parenteral nutrition. Spine (Phila Pa 1976). 1998 Jun 15;23(12):1401-5. doi: 10.1097/00007632-199806150-00019.'}, {'pmid': '7676333', 'type': 'BACKGROUND', 'citation': 'Lenke LG, Bridwell KH, Blanke K, Baldus C. Prospective analysis of nutritional status normalization after spinal reconstructive surgery. Spine (Phila Pa 1976). 1995 Jun 15;20(12):1359-67.'}, {'pmid': '17966019', 'type': 'BACKGROUND', 'citation': 'Ljungqvist O, Soop M, Hedstrom M. Why metabolism matters in elective orthopedic surgery: a review. Acta Orthop. 2007 Oct;78(5):610-5. doi: 10.1080/17453670710014293. No abstract available.'}, {'pmid': '11855922', 'type': 'BACKGROUND', 'citation': 'Malone DL, Genuit T, Tracy JK, Gannon C, Napolitano LM. Surgical site infections: reanalysis of risk factors. J Surg Res. 2002 Mar;103(1):89-95. doi: 10.1006/jsre.2001.6343.'}, {'pmid': '15303030', 'type': 'BACKGROUND', 'citation': 'McMulkin ML, Ferguson RL. Resting energy expenditure and respiratory quotient in adolescents following spinal fusion surgery. Spine (Phila Pa 1976). 2004 Aug 15;29(16):1831-5. doi: 10.1097/01.brs.0000134564.24874.10.'}]}, 'descriptionModule': {'briefSummary': 'This project is intended to determine the magnitude and duration of RMR changes in patients receiving orthopedic surgery. The result will help to guide postoperative nutrition recommendations in patients receiving orthopedic surgery.', 'detailedDescription': 'Surgery produces a catabolic response in the body that shifts metabolism from glucose to fat and protein. Despite no studies examining ACLR, studies of other orthopedic surgeries demonstrate increased postoperative energy expenditure, as well as a shift to beta-oxidation. Additionally, in most patients, these changes reverted to baseline within six weeks, although a subset of patients did not return to baseline until beyond 12 weeks.\n\nThis project will improve our understanding of magnitude and duration of RMR changes following orthopedic surgery, and the subsequent perioperative dietary suggestions that should be made to improve patient outcomes. Currently, postoperative dietary suggestions are not surgery nor patient specific. Determining how orthopedic surgery effects RMR will help to personalize perioperative treatment, rehabilitation, and recovery.\n\nBetter understanding the change in RMR following orthopedic surgery and implementing more accurate dietary modifications will help to ensure positive outcomes and control of infection following orthopedic surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects will be over the age of 15 years old undergoing elective orthopedic surgery at KU Medical Center.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any individual over 15 undergoing an orthopedic surgery.\n\nExclusion Criteria:\n\n* Pregnant female\n* \\< 15 years old'}, 'identificationModule': {'nctId': 'NCT06107959', 'briefTitle': 'Changes in Resting Metabolic Rate Following Orthopedic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Changes in Resting Metabolic Rate Following Orthopedic Surgery', 'orgStudyIdInfo': {'id': 'STUDY00150689'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Male', 'description': '50 male subjects undergoing orthopedic surgery.', 'interventionNames': ['Other: Pre-surgical nutrition, hydration, RMR, and body composition assessments', 'Other: Post-surgical nutrition, hydration, RMR and body composition assessments']}, {'label': 'Female', 'description': '50 female subjects undergoing orthopedic surgery', 'interventionNames': ['Other: Pre-surgical nutrition, hydration, RMR, and body composition assessments', 'Other: Post-surgical nutrition, hydration, RMR and body composition assessments']}], 'interventions': [{'name': 'Pre-surgical nutrition, hydration, RMR, and body composition assessments', 'type': 'OTHER', 'description': 'Urine sample, InBody device platform, Metabolic cart with hood to collect RMR.', 'armGroupLabels': ['Female', 'Male']}, {'name': 'Post-surgical nutrition, hydration, RMR and body composition assessments', 'type': 'OTHER', 'description': 'Same as pre-surgical tests at 1 week, 3 weeks, 6 weeks, and 12 weeks follow up time points.', 'armGroupLabels': ['Female', 'Male']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sharon Bradshaw', 'role': 'CONTACT', 'email': 'sbradshaw2@kumc.edu'}], 'facility': 'The University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'centralContacts': [{'name': 'Sharon Bradshaw', 'role': 'CONTACT', 'email': 'sbradshaw2@kumc.edu', 'phone': '913-945-6289'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lisa Vopat, MD', 'investigatorAffiliation': 'University of Kansas Medical Center'}}}}