Effect of Metformin on Patients With Osteoarthritis

Sponsor
Guangzhou First People's Hospital
Study ID
NCT05034029
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Metformin hydrochloride sustained release tablets — DRUG
    Oral
  • Placebo — DRUG
    Placebo

Study Details

This randomized controlled trial aims to investigate if metformin has osteoarthritis protective effects among overweighted knee osteoarthritis patients. The co-primary outcomes are changes in tibiofemoral cartilage volume and Western Ontario and McMaster Universities Arthritis Index (WOMAC) from baseline to month 24. The secondary outcomes are changes in visual analog scale (VAS)-assessed knee pain, tibiofemoral cartilage defect, effusion-synovitis volume, and tibiofemoral bone marrow lesion maximum size from baseline to month 24.

Key Dates

Start date
Aug 1, 2021
Status verified
Aug 2021
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
262 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Metformin
    Metformin hydrochloride sustained release tablet will administer orally in escalating doses to reduce side-effects and maintain masking: 0.5 g/day for the first two weeks, 1 g/day for the next 2 weeks, and then 2 g/day until the end of the study if tolerated. If the subject cannot tolerate the maximum dose (2 g/day), take their maximum tolerable dose. In case of adverse reaction, the researchers can determine whether the subject needs to reduce or stop the drug based on their discretion.
  • Placebo Comparator: Placebo
    Placebo will administer the same as the experimental drug.

Primary Outcome Measure

Change of tibiofemoral cartilage volume from baseline to 24 months follow up [ Time Frame: Baseline and 24 months follow up ]

Central Contacts

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