NCT07065591RecruitingEarly phase 1
Anti-Diabetic Drug, Exercise and Healthy Diet for Knee Osteoarthritis With Overweight/Obesity
Anti-Diabetic Drug, Exercise and Healthy Diet for Knee Osteoarthritis With Overweight/Obesity, a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 18 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 29 Jun 2025
- Start date
- 30 Aug 2026
- Primary completion date
- 17 Apr 2028
- Lead sponsor
- The University of Hong Kong
- Diseases
- Obesity
- NCT number
- NCT07065591
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 100
- From 30 Aug 2026 to the primary completion date, 17 Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent knee surgery of the same knee
- Concomitant neuromuscular diseases affecting lower limb function.
Other illness
- Preexisting diabetes on antidiabetic drug or drug allergy to metformin.
- renal or liver impairment precluding use of metformin.
Other
- 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.
- Significant bone loss.
- VitaminB12 deficiency
Who the study is looking for
- 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
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maclehose Medical Rehabilitation Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.