RECRUITING

Metformin Use in Patients Undergoing Total Joint Replacement Surgery

Description

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
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Related Conditions:

Hyperglycemia

Study Overview

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Study Details

Study overview

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.

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

Metformin Use in Patients Undergoing Total Joint Replacement Surgery

Condition
Hyperglycemia
Intervention / Treatment

-

Contacts and Locations

Portland

Oregon Health & Science University, Portland, Oregon, United States, 97239

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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
  • * 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

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Oregon Health and Science University,

Ryland Kagan, PRINCIPAL_INVESTIGATOR, Oregon Health and Science University

Study Record Dates

2025-09-30