Metformin Use in Patients Undergoing Total Joint Replacement Surgery

Hyperglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06280274
• Other study ID #: STUDY00025798
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: February 26, 2024
• Est. completion date: May 30, 2025

Study information

• Verified date: February 2024
• Source: Oregon Health and Science University
• Contact: Aidan Morrell
• Phone: 5034948211
• Email: morrella[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 30, 2025
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperglycemia

Intervention

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

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of participant enrollment	Feasibility defined by an average of four participants per month successfully enrolled and randomized.	3 months
Primary	Rate of appropriate study drug administration	Feasibility defined by =90% participants receiving 1000mg metformin or placebo daily by day of surgery, assessed via combination of self-report and counting of remaining tablets.	3 months
Primary	Rate of participant adherence to trial intervention per protocol	Feasibility defined by =90% participant adherence to trial intervention per protocol.	3 months
Primary	Rate of participant retention to 90-day follow up	Feasibility defined by =90% retention to follow up at 90 days.	3 months
Secondary	Perioperative glycemic variability	Defined as coefficient of variation (CV) = standard deviation / mean of blood glucose levels	3 months
Secondary	Sliding scale insulin utilization	Measured by total number of units administered from time of surgery to discharge.	3 months
Secondary	Hospital length of stay	Measured in days.	3 months
Secondary	90-day Rate of surgical site infection	Defined by criteria published by Centers for Disease Control and Prevention.	3 months
Secondary	90-day Rate of periprosthetic joint infection	Defined by criteria published in 2018 by Musculoskeletal Infection Society (MSIS).	3 months
Secondary	90-day Rate of mortality		3 months
Secondary	90-day rate of readmission		3 months

External Links

•   Metformin labeling