Metformin Use in Patients Undergoing Total Joint Replacement Surgery

Last updated: June 27, 2024
Sponsor: Oregon Health and Science University
Overall Status: Active - Recruiting

Phase

4

Condition

Diabetes And Hypertension

Diabetes Mellitus Types I And Ii

Diabetes Mellitus, Type 2

Treatment

Placebo

Metformin

Clinical Study ID

NCT06280274
STUDY00025798
  • Ages 18-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female, age 18-99 years

  • Undergoing total hip or total knee arthroplasty, including elective, primary, andrevision surgeries

  • Ability to take oral medication and be willing to adhere to the prescribed metforminregimen 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

Exclusion Criteria:

  • Advanced renal insufficiency (glomerular filtration rate (GFR) < 45, or chronickidney 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 impairedadults, prisoners

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 4
Study Start date:
June 27, 2024
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

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