Metformin Use in Patients Undergoing Total Joint Replacement Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-27

Study Completion Date

2025-09-15

Brief Summary

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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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Detailed Description

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Conditions

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Hyperglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Treatment

Oral metformin hydrochloride

Group Type EXPERIMENTAL

Metformin

Intervention Type 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.

Placebo

Placebo tablet

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo tablet

Interventions

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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.

Intervention Type DRUG

Placebo

Placebo tablet

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No