HyperglycemiaPhase 4NCT06280274
Metformin Use in Patients Undergoing Total Joint Replacement Surgery
A Phase 4 study testing Metformin in people with Hyperglycemia, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The goal of this pilot, randomized, single-blind, placebo-controlled trial is to evaluate the feasibility of and provide preliminary information for a multi-center randomized controlled trial that will assess the effects of metformin on blood sugar control in patients after total hip or total knee replacement surgery. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hyperglycemia
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2024to 15 Sep 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age 18-99 years
- Undergoing total hip or total knee arthroplasty, including elective, primary, and revision surgeries
- Ability to take oral medication and be willing to adhere to the prescribed metformin regimen regardless of current, past, or no metformin use.
- Note: Patients with or without type 2 diabetes are considered eligible. (E.g.)
- Type 2 diabetic on metformin
- Type 2 diabetic on metformin and other medication, including insulin
Show all 9Show fewer
- Type 2 diabetic on medication but not metformin
- Pre-diabetic
- Non-diabetic
Who cannot join
- Advanced renal insufficiency (glomerular filtration rate (GFR) < 45, or chronic kidney disease (CKD) stage 3B or higher)
- Advanced liver cirrhosis or failure (Child-Pugh class B or C)
- Congestive heart failure (New York Heart Association (NYHA) class 3 or 4)
- Current alcohol abuse within 30 days of surgery (>4 standard servings daily for men, >3 standard servings daily for women)
- Type 1 diabetes
- Received contrast dye within 48 hours of surgery
- Vulnerable populations: Children, pregnant women, neonates, decisionally impaired adults, prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Perioperative Metformin Use in Patients Undergoing Total Joint Replacement Surgery: A Pilot Study
The goal of this pilot, randomized, single-blind, placebo-controlled trial is to evaluate the feasibility of and provide preliminary information for a multi-center randomized controlled trial that will assess the effects of metformin on blood sugar control in patients after total hip or total knee replacement surgery.
The primary objective of this study is to assess the feasibility of conducting a large, randomized trial with regards to timely recruitment, study drug administration, protocol adherence, and overall retention in patients undergoing total joint arthroplasty.
Secondarily, the investigators aim to obtain preliminary estimates of group-specific outcome means and variances for primary and secondary outcomes of a larger future trial.
- Conditions
- Hyperglycemia
- Being tested
- Metformin, Placebo
- Keywords
- Arthroplasty, Hip, Knee, Metformin, glycemic variability
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Metformin 500mg oral once daily for 7 days, increased to 1000mg (500mg twice daily) for another 7 days, taken in morning and evening with meals, for a total of 14 days of treatment prior to surgery. Continue dose on day of surgery and up to post operative day 2, or until time of discharge, whichever happens first.
PlaceboOther
Placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Oral metformin hydrochloride Receives: Drug: Metformin |
| Placebo | Placebo comparator | Placebo tablet Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of participant enrollment
Feasibility defined by an average of four participants per month successfully enrolled and randomized.
Measured: 3 months
Rate of appropriate study drug administration
Feasibility defined by ≥90% participants receiving 1000mg metformin or placebo daily by day of surgery, assessed via combination of self-report and counting of remaining tablets.
Measured: 3 months
Rate of participant adherence to trial intervention per protocol
Feasibility defined by ≥90% participant adherence to trial intervention per protocol.
Measured: 3 months
Rate of participant retention to 90-day follow up
Feasibility defined by ≥90% retention to follow up at 90 days.
Measured: 3 months
Secondary outcomes (7)
Perioperative glycemic variability
Defined as coefficient of variation (CV) = standard deviation / mean of blood glucose levels
Measured: 3 months
Sliding scale insulin utilization
Measured by total number of units administered from time of surgery to discharge.
Measured: 3 months
Hospital length of stay
Measured in days.
Measured: 3 months
90-day Rate of surgical site infection
Defined by criteria published by Centers for Disease Control and Prevention.
Measured: 3 months
90-day Rate of periprosthetic joint infection
Defined by criteria published in 2018 by Musculoskeletal Infection Society (MSIS).
Measured: 3 months
90-day Rate of mortality
Measured: 3 months
90-day rate of readmission
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start27 Jun 2024
- Primary completion15 Sep 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryland Kagan, Oregon Health and Science University
- Investigators
- Ryland Kagan, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280274
- Sponsor's protocol ID
- STUDY00025798
- Status last verified
- Aug 2025
- First submitted
- 19 Feb 2024
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morrell A, Shelofsky S, Hoffman H, McCallister C, Huff TW, Schabel KL, O'Glasser AY, Kagan RP. Perioperative metformin use in patients undergoing total joint replacement surgery: protocol for a randomised, placebo-controlled pilot study. BMJ Open. 2025 Apr 8;15(4):e091446. doi: 10.1136/bmjopen-2024-091446.
PubMed 40204318
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Metformin Use in Patients Undergoing Total Joint Replacement Surgery: A Pilot Study
- ClinicalTrials.gov ID
- NCT06280274
- Acronym / sponsor ID
- STUDY00025798
- Conditions
- Hyperglycemia
- Keywords
- Arthroplasty, Hip, Knee, Metformin, glycemic variability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 28 Feb 2024 (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.
The goal of this pilot, randomized, single-blind, placebo-controlled trial is to evaluate the feasibility of and provide preliminary information for a multi-center randomized controlled trial that will assess the effects of metformin on blood sugar control in patients after total hip or total knee replacement surgery.
The primary objective of this study is to assess the feasibility of conducting a large, randomized trial with regards to timely recruitment, study drug administration, protocol adherence, and overall retention in patients undergoing total joint arthroplasty.
Secondarily, the investigators aim to obtain preliminary estimates of group-specific outcome means and variances for primary and secondary outcomes of a larger future trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: MetforminOral metformin hydrochloride |
| Placebo | Placebo comparator | Other: PlaceboPlacebo tablet |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female, age 18-99 years
- Undergoing total hip or total knee arthroplasty, including elective, primary, and revision surgeries
- Ability to take oral medication and be willing to adhere to the prescribed metformin regimen regardless of current, past, or no metformin use.
- Note: Patients with or without type 2 diabetes are considered eligible. (E.g.)
- Type 2 diabetic on metformin
Key exclusion criteria (7 listed)
- Advanced renal insufficiency (glomerular filtration rate (GFR) < 45, or chronic kidney disease (CKD) stage 3B or higher)
- Advanced liver cirrhosis or failure (Child-Pugh class B or C)
- Congestive heart failure (New York Heart Association (NYHA) class 3 or 4)
- Current alcohol abuse within 30 days of surgery (>4 standard servings daily for men, >3 standard servings daily for women)
- Type 1 diabetes
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 |
|---|---|---|
| MetforminMetformin 500mg oral once daily for 7 days, increased to 1000mg (500mg twice daily) for another 7 days, taken in morning and evening with meals, for a total of 14 days of treatment prior to surgery. Continue dose on day of surgery and up to post operative day 2, or until time of discharge, whichever happens first. | Drug | Treatment |
| PlaceboPlacebo tablet | Other | Placebo |
Primary outcome
Rate of participant enrollment
Time frame: 3 months
Feasibility defined by an average of four participants per month successfully enrolled and randomized.
Rate of appropriate study drug administration
Time frame: 3 months
Feasibility defined by ≥90% participants receiving 1000mg metformin or placebo daily by day of surgery, assessed via combination of self-report and counting of remaining tablets.
Rate of participant adherence to trial intervention per protocol
Time frame: 3 months
Feasibility defined by ≥90% participant adherence to trial intervention per protocol.
Rate of participant retention to 90-day follow up
Time frame: 3 months
Feasibility defined by ≥90% retention to follow up at 90 days.
7 secondary outcomes
Perioperative glycemic variability
Time frame: 3 months
Sliding scale insulin utilization
Time frame: 3 months
Hospital length of stay
Time frame: 3 months
90-day Rate of surgical site infection
Time frame: 3 months
90-day Rate of periprosthetic joint infection
Time frame: 3 months
90-day Rate of mortality
Time frame: 3 months
90-day rate of readmission
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Derived from this study: PubMed 40204318Morrell A, Shelofsky S, Hoffman H, McCallister C, Huff TW, Schabel KL, O'Glasser AY, Kagan RP. Perioperative metformin use in patients undergoing total joint replacement surgery: protocol for a randomised, placebo-controlled pilot study. BMJ Open. 2025 Apr 8;15(4):e091446. doi: 10.1136/bmjopen-2024-091446.
- Metformin labelingLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Hyperglycemia
Not yet recruitingObservational study
Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults
Obesity, Diabetes
Not yet recruiting
Effects of Mango on Insulin Sensitivity in Prediabetes
Pre Diabetes
Not yet recruitingEarly Phase 1
Efficacy of the pA1c®HI Postbiotic in Metabolic Regulation in Healthy Individuals With Hyperglycemia
Hyperglycemias, Prediabetes
Active, not recruiting
Insulin Balanced Infusion System
Hyperglycemia, Diabetes
Not yet recruitingObservational study
Unmasking Diabetes in Dialysis With Continuous Glucose Monitoring
End Stage Kidney Disease (ESKD), Hyperglycaemia
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. This study is not recruiting at the moment.
Ryland Kagan principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin in people with Hyperglycemia, run by Oregon Health and Science University 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 9 inclusion and 7 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: finished, as of the sponsor's last update on 5 Dec 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of participant enrollment (time frame: 3 months). The study lists 4 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 NCT06280274, which also lists 1 linked publication.
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 5 Dec 2025.