Metformin Use in Patients Undergoing Total Joint Replacement Surgery

NCT06280274 | Completed Phase 4 FDA Drug

• 1 other identifier: STUDY00025798
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Arthroplasty; Hip; Knee; Metformin; glycemic variability

Outcome Measures

Primary Outcomes (4)

• Rate of participant enrollment

  Feasibility defined by an average of four participants per month successfully enrolled and randomized.

  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.

  3 months

• Rate of participant adherence to trial intervention per protocol

  Feasibility defined by ≥90% participant adherence to trial intervention per protocol.

  3 months

• Rate of participant retention to 90-day follow up

  Feasibility defined by ≥90% retention to follow up at 90 days.

  3 months

Secondary Outcomes (7)

• Perioperative glycemic variability

  3 months

• Sliding scale insulin utilization

  3 months

• Hospital length of stay

  3 months

• 90-day Rate of surgical site infection

  3 months

• 90-day Rate of periprosthetic joint infection

  3 months

Study Arms (2)

Treatment

EXPERIMENTAL

Oral metformin hydrochloride

Drug: Metformin

Placebo

PLACEBO COMPARATOR

Placebo tablet

Other: Placebo

Interventions

Metformin DRUG

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.

Treatment

Placebo OTHER

Placebo tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Type 2 diabetic on medication but not metformin
• Pre-diabetic
• Non-diabetic

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• 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.

  PMID: 40204318 DERIVED

Related Links

• Metformin labeling

MeSH Terms

Conditions

Hyperglycemia

Interventions

Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Ryland Kagan

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Orthopaedics and Rehabilitation

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 28, 2024
• Study Start: June 27, 2024
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)