Preventing Injured Knees From osteoArthritis: Severity Outcomes

PHASE2RecruitingINTERVENTIONAL
Enrollment

512

Participants

Timeline

Start Date

May 6, 2024

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2029

Conditions
Osteoarthritis, KneePost-traumatic OsteoarthritisACL Tear
Interventions
DRUG

Metformin

Metformin is an oral anti-hyperglycemic agent widely used as first-line treatment for type II diabetes to improve glycemic control. It is the fourth most commonly prescribed drug in the United States. Participants will receive commercially available extended-release metformin 500mg tablets manufactured by Granules India Limited, Hyderabad, India and then sourced, packaged, and labeled for the study by Sharp Labs. The study will follow standard dosing procedures for extended-release metformin. Participants will begin by taking 1x500 mg pill once a day, and then the dose will be increased in 500 mg/day increments every 5 days as tolerated, up to a maximum dose of 1500 mg daily.

DRUG

Placebo

The study will use matching placebo tablets that are almost indistinguishable from the 500 mg metformin ER tablets. Participants will begin by taking 1x500 mg pill once a day, and then the dose will be increased in 500 mg/day increments every 5 days as tolerated, up to a maximum dose of 1500 mg daily.

Trial Locations (9)

10021

RECRUITING

Hospital for Special Surgery, New York

25599

RECRUITING

The University of North Carolina at Chapel Hill, Chapel Hill

30322

RECRUITING

Emory University, Atlanta

40504

RECRUITING

University of Kentucky, Lexington

43210

RECRUITING

The Ohio State University, Columbus

44195

RECRUITING

Cleveland Clinic, Cleveland

52242

RECRUITING

University of Iowa Hospitals and Clinics, Iowa City

68198

RECRUITING

University of Nebraska Medical Center, Omaha

02115

RECRUITING

Brigham and Women's Hospital, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Arthritis Foundation

OTHER

lead

Brigham and Women's Hospital

OTHER