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Anti-diabetic agent

Treatment for High Blood Sugar

Phase 4

Waitlist Available

Led By Ryland Kagan

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing total hip or total knee arthroplasty, including elective, primary, and revision surgeries

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study Summary

This trial aims to see if metformin can help control blood sugar in patients after hip or knee replacement surgery. The study will look at how feasible it is to conduct a larger trial in terms of

Who is the study for?

This trial is for individuals with high blood sugar who are undergoing total hip or knee replacement surgery. It's a pilot study to see if it's possible to do a larger trial on how well metformin controls blood sugar after these surgeries.Check my eligibility

What is being tested?

The study is testing the drug metformin against a placebo (a pill without any medicine) in patients having joint replacement surgery. The goal is to gather initial data on whether metformin helps control blood sugar levels post-surgery.See study design

What are the potential side effects?

Metformin can cause side effects like stomach upset, diarrhea, nausea, and loss of appetite. Rarely, it may lead to low blood sugar or a serious condition called lactic acidosis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am having a hip or knee replacement surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of appropriate study drug administration

Rate of participant adherence to trial intervention per protocol

Rate of participant enrollment

+1 more

Secondary outcome measures

90-day Rate of mortality

90-day Rate of periprosthetic joint infection

90-day Rate of surgical site infection

+4 more

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221

13%

Nasopharyngitis

10%

Hyperhidrosis

Hunger

Tremor

Asthenia

Hypoglycaemia

Squamous cell carcinoma of the tongue

Femoral neck fracture

100%

80%

60%

40%

20%

Study treatment Arm

Vildagliptin (LAF237)

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TreatmentExperimental Treatment1 Intervention

Oral metformin hydrochloride

Group II: PlaceboPlacebo Group1 Intervention

Placebo tablet

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Metformin

2006

Completed Phase 4

~2430

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor

974 Previous Clinical Trials

7,385,872 Total Patients Enrolled

Ryland KaganPrincipal InvestigatorOregon Health and Science University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this therapeutic approach received official endorsement from the FDA?

"Given that this treatment has already received approval, our team at Power rates its safety as a 3 on a scale from 1 to 3."

Answered by AI

Which individuals meet the criteria for eligibility to enroll in this medical research study?

"Enrollment in this trial requires elevated blood glucose levels and a patient age ranging from 18 to 99 years. The study has capacity for up to 40 participants."

Answered by AI

Is the registration process currently ongoing for this clinical trial?

"According to the details provided on clinicaltrials.gov, recruitment for this trial is currently closed. The study was first listed on February 26th, 2024 and last modified on February 19th, 2024. Although not actively enrolling participants now, there are a total of 76 other trials seeking candidates at present."

Answered by AI

Is there an age limit for individuals participating in this clinical trial?

"Patients between the ages of 18 and 99 are eligible for enrollment in this study. There are separate trials available for individuals under 18 years old and those over 65, with a total of six and sixty studies respectively."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Metformin Use in Patients Undergoing Total Joint Replacement Surgery

Ryland Kagan 2024. "Metformin Use in Patients Undergoing Total Joint Replacement Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06280274.