Tests metformin with diet and exercise for knee osteoarthritis and excess weight

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 40 to 80 with knee osteoarthritis who are overweight or obese and have had knee pain for 6+ months. They must have been referred for joint replacement consideration.

Age

40 to 80 years

Sex

Men and women

Disease stage

Knee osteoarthritis meeting the American College of Rheumatology criteria, referred for consideration for joint replacement. Knee pain for 6+ months with a pain score (VAS) above 40mm/100mm.

Earlier treatment

People already taking an antidiabetic drug for diabetes cannot join.

Biomarker or test result

Body mass index of 23 kg/m2 or more (overweight or obesity, by the Hong Kong Centre for Health Protection definition).

Main reasons for not taking part

• Severe knee osteoarthritis on X-ray (Kellgren-Lawrence grade 4) or very severe knee pain (VAS above 80mm/100mm)
• Inflammatory arthritis such as rheumatoid arthritis or crystal arthritis
• Diabetes already treated with antidiabetic drugs, or allergy to metformin
• Recent surgery on the same knee, or significant bone loss
• Kidney or liver problems that rule out metformin, or vitamin B12 deficiency

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 40 and 80 years old?YesNo

What the trial wants to find out

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.

The 2 groups in the trial

• Intervention groupTreatment being tested

  This group of patients 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.

  Treatment: Metformin

• PlaceboPlacebo, for comparison

  This group of patients 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.