Hyperglycemia
Conditions
Keywords
Arthroplasty, Hip, Knee, Metformin, glycemic variability
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.
Interventions
DRUGMetformin
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.
OTHERPlacebo
Placebo tablet
Sponsors
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of participant enrollment | 3 months | Feasibility defined by an average of four participants per month successfully enrolled and randomized. |
| Rate of appropriate study drug administration | 3 months | 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. |
| Rate of participant adherence to trial intervention per protocol | 3 months | Feasibility defined by ≥90% participant adherence to trial intervention per protocol. |
| Rate of participant retention to 90-day follow up | 3 months | Feasibility defined by ≥90% retention to follow up at 90 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 90-day Rate of periprosthetic joint infection | 3 months | Defined by criteria published in 2018 by Musculoskeletal Infection Society (MSIS). |
| Perioperative glycemic variability | 3 months | Defined as coefficient of variation (CV) = standard deviation / mean of blood glucose levels |
| 90-day rate of readmission | 3 months | — |
| 90-day Rate of mortality | 3 months | — |
| Sliding scale insulin utilization | 3 months | Measured by total number of units administered from time of surgery to discharge. |
| Hospital length of stay | 3 months | Measured in days. |
| 90-day Rate of surgical site infection | 3 months | Defined by criteria published by Centers for Disease Control and Prevention. |
Countries
United States
Outcome results
None listed