COMPLETED

Metformin Use in Patients Undergoing Total Joint Replacement Surgery

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Perioperative Metformin Use in Patients Undergoing Total Joint Replacement Surgery: A Pilot Study

Quick Facts

Study Start:2024-06-27
Study Completion:2025-09-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06280274

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female, age 18-99 years
  2. * Undergoing total hip or total knee arthroplasty, including elective, primary, and revision surgeries
  3. * Ability to take oral medication and be willing to adhere to the prescribed metformin regimen regardless of current, past, or no metformin use.
  4. * Type 2 diabetic on metformin
  5. * Type 2 diabetic on metformin and other medication, including insulin
  6. * Type 2 diabetic on medication but not metformin
  7. * Pre-diabetic
  8. * Non-diabetic
  1. * Advanced renal insufficiency (glomerular filtration rate (GFR) \< 45, or chronic kidney disease (CKD) stage 3B or higher)
  2. * Advanced liver cirrhosis or failure (Child-Pugh class B or C)
  3. * Congestive heart failure (New York Heart Association (NYHA) class 3 or 4)
  4. * Current alcohol abuse within 30 days of surgery (\>4 standard servings daily for men, \>3 standard servings daily for women)
  5. * Type 1 diabetes
  6. * Received contrast dye within 48 hours of surgery
  7. * Vulnerable populations: Children, pregnant women, neonates, decisionally impaired adults, prisoners

Contacts and Locations

Principal Investigator

Ryland Kagan
PRINCIPAL_INVESTIGATOR
Oregon Health and Science University

Study Locations (Sites)

Oregon Health & Science University
Portland, Oregon, 97239
United States

Collaborators and Investigators

Sponsor: Oregon Health and Science University

  • Ryland Kagan, PRINCIPAL_INVESTIGATOR, Oregon Health and Science University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-27
Study Completion Date2025-09-15

Study Record Updates

Study Start Date2024-06-27
Study Completion Date2025-09-15

Terms related to this study

Keywords Provided by Researchers

  • Arthroplasty
  • Hip
  • Knee
  • Metformin
  • glycemic variability

Additional Relevant MeSH Terms

  • Hyperglycemia