Changes in Resting Metabolic Rate Following Orthopedic Surgery

October 24, 2023 updated by: Lisa Vopat, MD, University of Kansas Medical Center
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

This 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.

Better 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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Subjects will be over the age of 15 years old undergoing elective orthopedic surgery at KU Medical Center.

Description

Inclusion Criteria:

  • Any individual over 15 undergoing an orthopedic surgery.

Exclusion Criteria:

  • Pregnant female
  • < 15 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Male
50 male subjects undergoing orthopedic surgery.
Other: Pre-surgical nutrition, hydration, RMR, and body composition assessments
Urine sample, InBody device platform, Metabolic cart with hood to collect RMR.
Other: Post-surgical nutrition, hydration, RMR and body composition assessments
Same as pre-surgical tests at 1 week, 3 weeks, 6 weeks, and 12 weeks follow up time points.
Female
50 female subjects undergoing orthopedic surgery
Other: Pre-surgical nutrition, hydration, RMR, and body composition assessments
Urine sample, InBody device platform, Metabolic cart with hood to collect RMR.
Other: Post-surgical nutrition, hydration, RMR and body composition assessments
Same as pre-surgical tests at 1 week, 3 weeks, 6 weeks, and 12 weeks follow up time points.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the magnitude of the change in RMR of patients receiving orthopedic surgery.
Time Frame: 12 weeks
RMR = (9.99 X actual weight*)+ (6.25 X height*) - (4.92 X age) - 161*use weight in kilograms (kilogram), height in centimeters (cm).
12 weeks
To observe the amount of time it takes the RMR to return to baseline.
Time Frame: 12 weeks
calculation in number of weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

October 12, 2023

First Submitted That Met QC Criteria

October 24, 2023

First Posted (Actual)

October 30, 2023

Study Record Updates

Last Update Posted (Actual)

October 30, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00150689

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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