NCT06280274

Metformin Use in Patients Undergoing Total Joint Replacement Surgery

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Metformin	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.
OTHER	Placebo	Placebo tablet

Timeline

• Start date: 2024-06-27
• Primary completion: 2025-09-15
• Completion: 2025-09-15
• First posted: 2024-02-28
• Last updated: 2025-12-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study