NCT07065591 Anti-Diabetic Drug, Exercise and Healthy Diet for Knee Osteoarthritis With Overweight/Obesity
| NCT ID | NCT07065591 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | The University of Hong Kong |
| Condition | Osteoarthritis (OA) of the Knee |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-08-30 |
| Primary Completion | 2028-04-17 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2026-08-30 with a primary completion date of 2028-04-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07065591 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 80 Years, studying Osteoarthritis (OA) of the Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07065591 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07065591 currently recruiting?
Yes, NCT07065591 is actively recruiting participants. Contact the research team at laucml@hku.hk for enrollment information.
Where is the NCT07065591 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT07065591 clinical trial?
NCT07065591 is sponsored by The University of Hong Kong. The trial plans to enroll 100 participants.