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WithdrawnPhase 1/2

The AMPK Modulator Metformin as a Novel Adjunct to Conventional Therapy in Patients With Knee Osteoarthritis

Key facts

Who runs it
Sadat City University
Where
Egypt1 site in 1 countryChoose a country to see its sites
Trial code
Status
Withdrawn
Phase
Phase 1/2
Started
16 Feb 2021
Ended
31 Dec 2024
Type of study
Interventional, 2 groups
Treatments tested
  • Metformin
  • Placebo
Record updated
14 July 2025
Why it stopped
Institutional and funding constrains

Who can take part

Age
30 years to 60 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • Primary osteoarthritis Patients recruited were between 30 to 60 years of age, with X-ray confirmed Kellgren-Lawrence grade13 II or III severity primary tibiofemoral OA, according to the American College of Rheumatology criteria

Who cannot take part

  • presented with active concomitant gastroduodenal disorders, hepatic and renal impairment within last 30 days prior to receiving the study drug
  • had previous or ongoing treatment with oral SYSDOA (e.g., glucosamine sulphate, chondroitin sulphate, diacerein, piascledine), anti-depressants, tranquillisers, antacids or antibiotics; were having active cardiac lesion or hypertension, were pregnant females and those who were planning their pregnancy during the study
  • Patients who received oral, intramuscular, intraarticular or soft tissue injections of corticosteroids within last eight weeks before receiving the first dose of the study medication, or had undergone joint lavage and arthroscopic procedures in the previous 6 months, were also excluded
  • were having a known hypersensitivity to the used medications
  • have persistent diarrhoea or laxative use; severe gastrointestinal disorders, severe obesity, severe parenchymal organ disease, or anaemia (haemoglobin< 10.0 g/ dl or haematocrit < 30%)
  • were of age less than 30 years or more than 60 years
  • Those patients were excluded from the present study who:
  • were diagnosed to have any inflammatory arthritis, gout or acute trauma of the knee, hip or spine; accompanying OA of the hip of sufficient severity to interfere with the functional assessment of the knee

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

metformin alleviates drug-induced osteoarthritis (OA)-like change in mice knee joint through activating autophagy and downregulating apoptosis. Metformin exerts its protective effects against OA through the AMPKa2/ SIRT1 pathway. Metformin suppresses IL-1β-induced oxidative and osteoarthritis-like inflammatory changes by enhancing the SIRT3/PINK1/Parkin signaling pathway, thereby indicating metformin's potential in prevention and treatment of osteoarthritic joint disease.

The 2 groups in the trial

  • MetforminTreatment being tested

    Metformin 1000 mg daily plus Celecoxib 200mg capsule

  • PlaceboTreatment being tested

    Placebo tablet daily plus Celecoxib 200mg capsule

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
The AMPK Modulator Metformin as a Novel Adjunct to Conventional Therapy in Patients With Knee Osteoarthritis: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial
Record updated
14 July 2025