Clinical trial NCT06280274: Metformin Use in Patients Undergoing Total Joint Replacement Surgery
Official title: Perioperative Metformin Use in Patients Undergoing Total Joint Replacement Surgery: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hyperglycemia
Keywords: Arthroplasty
Hip
Knee
Metformin
glycemic variability
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Rate of participant enrollment
timeFrame: 3 months
measure: Rate of appropriate study drug administration
timeFrame: 3 months
measure: Rate of participant adherence to trial intervention per protocol
timeFrame: 3 months
measure: Rate of participant retention to 90-day follow up
timeFrame: 3 months
Secondary outcomes:
measure: Perioperative glycemic variability
timeFrame: 3 months
measure: Sliding scale insulin utilization
timeFrame: 3 months
measure: Hospital length of stay
timeFrame: 3 months
measure: 90-day Rate of surgical site infection
timeFrame: 3 months
measure: 90-day Rate of periprosthetic joint infection
timeFrame: 3 months
measure: 90-day Rate of mortality
timeFrame: 3 months
measure: 90-day rate of readmission
timeFrame: 3 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Ryland Kagan
role: PRINCIPAL_INVESTIGATOR
References: