Metformin Use in Patients Undergoing Total Joint Replacement Surgery

Oregon Health & Science University (OHSU)

Status and phase: Completed; Phase 4

Conditions: Hyperglycemia

Treatments: Other: Placebo; Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT06280274

STUDY00025798

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups, including a placebo group

Treatment

Experimental group

Description:

Oral metformin hydrochloride

Treatment:

Drug: Metformin

Placebo

Placebo Comparator group

Description:

Placebo tablet

Treatment:

Other: Placebo