Metabolism; Disorder, PostproceduralNCT06107959
Changes in Resting Metabolic Rate Following Orthopedic Surgery
An observational study of Metabolism; Disorder, Postprocedural and Resting Metabolic Rate, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Metabolism; Disorder, Postprocedural, Resting Metabolic Rate, Post Operative Nutrition
- What is being tested?
- Pre-surgical nutrition, hydration, RMR, and body composition assessments and Post-surgical nutrition, hydration, RMR and body composition assessments
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2023to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects will be over the age of 15 years old undergoing elective orthopedic surgery at KU Medical Center.
Who may be able to join
- Any individual over 15 undergoing an orthopedic surgery.
Who cannot join
- Pregnant female
- < 15 years old
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Kansas Medical Center
Kansas City, Kansas, 66160
Sharon Bradshaw, sbradshaw2@kumc.edu
About this study
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.
Read the 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.
- Being tested
- Pre-surgical nutrition, hydration, RMR, and body composition assessments, Post-surgical nutrition, hydration, RMR and body composition assessments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-surgical nutrition, hydration, RMR, and body composition assessmentsOther
Urine sample, InBody device platform, Metabolic cart with hood to collect RMR.
Post-surgical nutrition, hydration, RMR and body composition assessmentsOther
Same as pre-surgical tests at 1 week, 3 weeks, 6 weeks, and 12 weeks follow up time points.
| Study group | Role | What they receive |
|---|---|---|
| Male | 50 male subjects undergoing orthopedic surgery. Receives: Other: Pre-surgical nutrition, hydration, RMR, and body composition assessments; Other: Post-surgical nutrition, hydration, RMR and body composition assessments | |
| Female | 50 female subjects undergoing orthopedic surgery Receives: Other: Pre-surgical nutrition, hydration, RMR, and body composition assessments; Other: Post-surgical nutrition, hydration, RMR and body composition assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the magnitude of the change in RMR of patients receiving orthopedic surgery.
RMR = (9.99 X actual weight*)+ (6.25 X height*) - (4.92 X age) - 161*use weight in kilograms (kilogram), height in centimeters (cm).
Measured: 12 weeks
To observe the amount of time it takes the RMR to return to baseline.
calculation in number of weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start10 Oct 2023
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Metabolism; Disorder, PostproceduralStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Vopat, MD, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107959
- Sponsor's protocol ID
- STUDY00150689
- Status last verified
- May 2026
- First submitted
- 12 Oct 2023
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 3283387Hu 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.
PubMed 9654632Lenke 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.
PubMed 7676333Ljungqvist 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.
PubMed 17966019Malone 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.
PubMed 11855922McMulkin 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.
PubMed 15303030
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Resting Metabolic Rate Following Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT06107959
- Acronym / sponsor ID
- STUDY00150689
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Male | – | Other: Pre-surgical nutrition, hydration, RMR, and body composition assessments, Other: Post-surgical nutrition, hydration, RMR and body composition assessments50 male subjects undergoing orthopedic surgery. |
| Female | – | Other: Pre-surgical nutrition, hydration, RMR, and body composition assessments, Other: Post-surgical nutrition, hydration, RMR and body composition assessments50 female subjects undergoing orthopedic surgery |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects will be over the age of 15 years old undergoing elective orthopedic surgery at KU Medical Center.
Key inclusion criteria (1 listed)
- Any individual over 15 undergoing an orthopedic surgery.
Key exclusion criteria (2 listed)
- Pregnant female
- < 15 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-surgical nutrition, hydration, RMR, and body composition assessmentsUrine sample, InBody device platform, Metabolic cart with hood to collect RMR. | Other | Female, Male |
| Post-surgical nutrition, hydration, RMR and body composition assessmentsSame as pre-surgical tests at 1 week, 3 weeks, 6 weeks, and 12 weeks follow up time points. | Other | Female, Male |
Primary outcome
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).
To observe the amount of time it takes the RMR to return to baseline.
Time frame: 12 weeks
calculation in number of weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Background: PubMed 3283387Braga 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.
- Background: PubMed 9654632Hu 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.
- Background: PubMed 7676333Lenke 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.
- Background: PubMed 17966019Ljungqvist 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.
- Background: PubMed 11855922Malone 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.
- Background: PubMed 15303030McMulkin 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolism; Disorder, Postprocedural and Resting Metabolic Rate, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharon Bradshaw (913-945-6289, sbradshaw2@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the magnitude of the change in RMR of patients receiving orthopedic surgery. (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06107959, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.