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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Oral metformin hydrochloride |
|
| Placebo | Placebo Comparator | Placebo tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of participant enrollment | Feasibility defined by an average of four participants per month successfully enrolled and randomized. | 3 months |
| 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 |
| Rate of participant adherence to trial intervention per protocol | Feasibility defined by ≥90% participant adherence to trial intervention per protocol. | 3 months |
| Rate of participant retention to 90-day follow up | Feasibility defined by ≥90% retention to follow up at 90 days. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative glycemic variability | Defined as coefficient of variation (CV) = standard deviation / mean of blood glucose levels | 3 months |
| Sliding scale insulin utilization | Measured by total number of units administered from time of surgery to discharge. |
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Inclusion Criteria:
Note: Patients with or without type 2 diabetes are considered eligible. (E.g.)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryland Kagan | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40204318 | Derived | Morrell A, Shelofsky S, Hoffman H, McCallister C, Huff TW, Schabel KL, O'Glasser AY, Kagan RP. Perioperative metformin use in patients undergoing total joint replacement surgery: protocol for a randomised, placebo-controlled pilot study. BMJ Open. 2025 Apr 8;15(4):e091446. doi: 10.1136/bmjopen-2024-091446. |
| Label | URL |
|---|---|
| Metformin labeling | View source |
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| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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Randomized controlled trial
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|
| Placebo | Other | Placebo tablet |
|
| 3 months |
| Hospital length of stay | Measured in days. | 3 months |
| 90-day Rate of surgical site infection | Defined by criteria published by Centers for Disease Control and Prevention. | 3 months |
| 90-day Rate of periprosthetic joint infection | Defined by criteria published in 2018 by Musculoskeletal Infection Society (MSIS). | 3 months |
| 90-day Rate of mortality | 3 months |
| 90-day rate of readmission | 3 months |