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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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

Locations
United States
Oregon
Oregon Health & Science University
RECRUITING
Portland
Contact Information
Primary
Aidan Morrell
morrella@ohsu.edu
5034948211
Backup
Ryland Kagan
kagan@ohsu.edu
5034945649
Time Frame
Start Date: 2024-06-27
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 40
Treatments
Experimental: Treatment
Oral metformin hydrochloride
Placebo_comparator: Placebo
Placebo tablet
Related Therapeutic Areas
Sponsors
Leads: Oregon Health and Science University

This content was sourced from clinicaltrials.gov