Skip to main content
OpenTrials
Completed

NCT Number: NCT06280274

Metformin Use in Patients Undergoing Total Joint Replacement Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hyperglycemia Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Placebo

Other

Placebo tablet

Primary outcomes

  1. Rate of participant enrollment

    Time frame: 3 months

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

  2. 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.

  3. Rate of participant adherence to trial intervention per protocol

    Time frame: 3 months

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

  4. Rate of participant retention to 90-day follow up

    Time frame: 3 months

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

Secondary outcomes

  1. Perioperative glycemic variability

    Time frame: 3 months

    Defined as coefficient of variation (CV) = standard deviation / mean of blood glucose levels

  2. Sliding scale insulin utilization

    Time frame: 3 months

    Measured by total number of units administered from time of surgery to discharge.

  3. Hospital length of stay

    Time frame: 3 months

    Measured in days.

  4. 90-day Rate of surgical site infection

    Time frame: 3 months

    Defined by criteria published by Centers for Disease Control and Prevention.

  5. 90-day Rate of periprosthetic joint infection

    Time frame: 3 months

    Defined by criteria published in 2018 by Musculoskeletal Infection Society (MSIS).

  6. 90-day Rate of mortality

    Time frame: 3 months

  7. 90-day rate of readmission

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

Perioperative Metformin Use in Patients Undergoing Total Joint Replacement Surgery: A Pilot Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 28, 2024
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.