Metformin as Adjuvant Therapy in Obese Knee Osteoarthritis Patients
1 other identifier
interventional
50
1 country
1
Brief Summary
This study aims to evaluate the possible efficacy and safety of addition of metformin to celecoxib in patients with knee osteoarthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 knee-osteoarthritis
Started Feb 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2022
CompletedFirst Submitted
Initial submission to the registry
November 28, 2022
CompletedFirst Posted
Study publicly available on registry
December 6, 2022
CompletedDecember 7, 2022
December 1, 2022
1.1 years
November 28, 2022
December 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Measure change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) at baseline and after 12weeks of treatment.
12 weeks
Weight (Kg)
Measure change in weight in kilograms at baseline and after 12weeks of treatment.
12 weeks
Secondary Outcomes (4)
Cartilage Oligomeric Matrix Protein (COMP)
12 weeks
C-terminal crosslinked telopeptide of type I collagen (CTX-1)
12 weeks
Interleukin 1-beta (IL-1β)
12 weeks
Adverse drug events
12 weeks
Study Arms (2)
Placebo group
EXPERIMENTALPlacebo tablet twice daily + celecoxib 200mg capsule once daily for 12 weeks.
Metformin group
EXPERIMENTALMetformin 500mg tablet twice daily + celecoxib 200mg capsule once daily for 12 weeks.
Interventions
Metformin (500mg/12hr) + celecoxib (200mg/day) for three months.
Eligibility Criteria
You may qualify if:
- Patients have symptomatic and radiological evidence of OA in one or both knee joints.
- Age ≥ 45 years.
- Both obese male and female will be included (BMI ≥ 30 kg/m²).
You may not qualify if:
- Patients with inflammatory rheumatic diseases, crystal deposition arthritis or infection-induced OA.
- Patient with hypertension or diabetes mellitus.
- Patient with hepatic or renal impairment.
- Patients who have active peptic ulcer.
- Patients with positive malignancy.
- Steroid injection into the affected knee joint within 3 months of recruitment for the study.
- Pregnant or lactating female patients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Study Sites (1)
Tanta university
Tanta, Gharbia Governorate, 31527, Egypt
Related Publications (1)
Aiad AAE, El-Haggar SM, El-Barbary AM, El-Afify DR. Metformin as adjuvant therapy in obese knee osteoarthritis patients. Inflammopharmacology. 2024 Aug;32(4):2349-2359. doi: 10.1007/s10787-024-01495-y. Epub 2024 Jun 13.
PMID: 38869746DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sahar M El-Haggar, Professor
Tanta University
- STUDY CHAIR
Amal M El-Barbary, Professor
Tanta University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- pharmacist
Study Record Dates
First Submitted
November 28, 2022
First Posted
December 6, 2022
Study Start
February 1, 2021
Primary Completion
March 12, 2022
Study Completion
April 15, 2022
Last Updated
December 7, 2022
Record last verified: 2022-12