RECRUITING Early Phase 1 ClinicalTrials.gov

Anti-Diabetic Drug, Exercise and Healthy Diet for Knee Osteoarthritis With Overweight/Obesity

Sponsor: The University of Hong Kong • ClinicalTrials.gov ID: NCT07065591

Registry updated: 2026-08-18

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Description

Obesity is associated with increased pain with knee osteoarthritis and increase progression of knee osteoarthritis while weight loss intervention has been shown to reduce pain and requirement of total knee replacement. In this study, the investigators will assess using diet modification with exercise, and metformin, a common, safe, diabetes mellitus medication that has been in use for 70 years to achieve better weight control to reduce knee pain. This helps the investigators to understand whether the combined treatment can reduce joint pain, reduce body weight and improve symptoms and requirement of total knee replacement.

Interventions

Metformin (Drug)
The intervention group will receive metformin (max: 500mgx4=2000mg daily). Both groups will start with an initial dose of 500mg daily and the dose will be gradually titrated to 2000mg daily in 6 weeks to allow patients adopting to the gastrointestinal symptoms. Both groups shall be put on metformin or placebo for 6months and then both groups will stop their respective medications and continue on diet modification and exercise therapy only.
Placebo (Other)
The placebo group will receive placebo. The placebos will be manufactured with Good Manufacturing Practice (GMP) standard such that each placebo pill will look like metformin pill (500mg). Both groups will start with an initial dose of 500mg daily and the dose will be gradually titrated to 2000mg daily in 6 weeks to allow patients adopting to the gastrointestinal symptoms. Both groups shall be put on metformin or placebo for 6months and then both groups will stop their respective medications and continue on diet modification and exercise therapy only.

Eligibility criteria

Inclusion Criteria: * Men and women age between 40 and 80 years old, with overweight or obesity (body mass index ≥23 kg/m2) according to Hong Kong Centre for Health Protection definition of overweight and obesity. * Knee pain for 6+ months with Visual Analogue Scale (VAS) \> 40mm/100mm and * Meet the American College of Rheumatology criteria for knee OA * OA referred for consideration for joint replacement Exclusion Criteria: * Severe radiographic knee OA (Kellgren-Lawrence grade 4) or severe knee pain (VAS\>80mm/100 mm) that could not tolerate further conservative management; * inflammatory arthritis like rheumatoid arthritis, crystal arthritis, etc. * Preexisting diabetes on antidiabetic drug or drug allergy to metformin. * Recent knee surgery of the same knee * Significant bone loss. * Concomitant neuromuscular diseases affecting lower limb function. * renal or liver impairment precluding use of metformin. * VitaminB12 deficiency

Conditions

Osteoarthritis (OA) of the Knee

Locations

Maclehose Medical Rehabilitation — Hong Kong, Sandy Bay, Hong Kong

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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