Using Metformin to Manage Blood Sugar in Joint Replacement Surgery Patients
Perioperative Metformin Use in Patients Undergoing Total Joint Replacement Surgery: A Pilot Study
This study is testing if metformin can help manage blood sugar levels in people having hip or knee replacement surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT06280274 on ClinicalTrials.gov |
What this trial studies
This pilot trial aims to evaluate the feasibility of conducting a larger randomized controlled trial assessing the effects of metformin on blood sugar control in patients undergoing total hip or knee replacement surgery. It will involve a randomized, single-blind, placebo-controlled design to determine timely recruitment, adherence to the metformin regimen, and overall retention of participants. The study will also gather preliminary data on outcomes related to glycemic control post-surgery, which will inform future larger trials.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-99 undergoing total hip or knee arthroplasty, regardless of their diabetes status.
Not a fit: Patients with advanced renal insufficiency, liver cirrhosis, congestive heart failure, or those with type 1 diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve blood sugar management in patients undergoing joint replacement surgery, potentially leading to better surgical outcomes.
How similar studies have performed: While this approach is being explored in this pilot trial, similar studies assessing metformin's effects in surgical settings have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Portland, Oregon
- Oregon Health & Science University — Portland, Oregon, United States (Recruiting)
Study contacts
- Principal investigator: Ryland Kagan — Oregon Health and Science University
- Study coordinator: Aidan Morrell
- Email: morrella@ohsu.edu
- Phone: 5034948211
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.