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WithdrawnNCT04767841Updated Jul 14, 2025

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

A Phase 1/2 interventional study of Metformin and Placebo in Osteo Arthritis Knee, sponsored by Sadat City University. Withdrawn at 1 site in Egypt. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-07-14.

Sponsored by Sadat City University · Phase 1/2, Interventional, and Treatment

Why this study was withdrawn
Institutional and funding constrains
Phase
Phase 1/2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
30 Years to 60 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Osteo Arthritis Knee
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In context

Lead sponsor

Sadat City University is the lead sponsor of 23 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

Those patients were excluded from the present study who:

  • were of age less than 30 years or more than 60 years
  • presented with active concomitant gastroduodenal disorders, hepatic and renal impairment within last 30 days prior to receiving the study drug
  • 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
  • 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
  • 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%).
  • 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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Metformin

    Metformin 1000 mg daily plus Celecoxib 200mg capsule

    Drug: Metformin

  • Experimental
    Placebo

    Placebo tablet daily plus Celecoxib 200mg capsule

    Drug: Placebo

Interventions

  • DrugMetformin

    Metformin 1000mg tablet plus celecoxib 200 mg capsule

  • DrugPlacebo

    Placebo tablet plus celecoxib 200 mg capsule

06

What researchers measure

Primary outcomes

  1. Visual Analogue scale assessment of pain

    the change of Visual Analogue Scale (VAS) pain score from baseline to posttreatment

    Time frame: week 12

Secondary outcomes

  1. WOMAC change

    the change of WOMAC Osteoarthritis Index from baseline to posttreatment

    Time frame: week 12

  2. the change of Short Form 36 Questionnaire (SF-36) score from baseline to posttreatment

    The SF-36 is a generic instrument to assess health-related quality of life. It consists of 36 questions and assesses 8 dimensions: physical functioning, role physical, pain index, general health, vitality, social functioning, role emotional, and mental health index. It also provides 2 summary measures of physical and mental components. The SF-36 score ranges from 0 to 100, with higher scores indicating better health status.

    Time frame: week 12

  3. Adverse drug reaction

    Clinical side effects

    Time frame: 12 weeks

  4. AMPK expression

    AMPK gene expression

    Time frame: 12 weeks

  5. Serum level Tumor necrosis factor- alpha (TNF-α)

    Serum level Tumor necrosis factor- alpha (TNF-α)

    Time frame: 12 weeks

  6. Serum levels of IL-1β

    Serum levels of IL-1β

    Time frame: 12 weeks

  7. IL-17

    Serum levels of IL-17

    Time frame: 12 weeks

07

Study locations

1 site
  • Faculty of Pharmacy
    Shibīn al Kawm, Menoufia 13829, Egypt
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Icf

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04767841
Lead sponsor
Sadat City University
Responsible party
Mahmoud Samy Abdallah (Principle Investigator, Sadat City University) — Principal investigator
First posted
Feb 23, 2021
Start date
Feb 16, 2021
Primary completion
Jun 30, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Jul 14, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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