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Metformin as Adjuvant Therapy in Obese Knee Osteoarthritis Patients

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Placebo Tablet
Metformin Hcl 500Mg Tab
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Metformin, knee osteoarthritis

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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). Exclusion Criteria: 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.

Sites / Locations

  • Tanta university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Placebo group

Metformin group

Arm Description

Placebo tablet twice daily + celecoxib 200mg capsule once daily for 12 weeks.

Metformin 500mg tablet twice daily + celecoxib 200mg capsule once daily for 12 weeks.

Outcomes

Primary Outcome Measures

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.
Weight (Kg)
Measure change in weight in kilograms at baseline and after 12weeks of treatment.

Secondary Outcome Measures

Cartilage Oligomeric Matrix Protein (COMP)
Measure change in Cartilage Oligomeric Matrix Protein (COMP) serum level at baseline and after 12weeks of treatment.
C-terminal crosslinked telopeptide of type I collagen (CTX-1)
Measure change in C-terminal crosslinked telopeptide of type I collagen (CTX-1) serum level at baseline and after 12weeks of treatment.
Interleukin 1-beta (IL-1β)
Measure change in Interleukin 1-beta (IL-1β) serum level at baseline and after 12weeks of treatment.
Adverse drug events
side effects

Full Information

First Posted
November 28, 2022
Last Updated
December 5, 2022
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT05638893
Brief Title
Metformin as Adjuvant Therapy in Obese Knee Osteoarthritis Patients
Official Title
Metformin as Adjuvant Therapy in Obese Knee Osteoarthritis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
March 12, 2022 (Actual)
Study Completion Date
April 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study aims to evaluate the possible efficacy and safety of addition of metformin to celecoxib in patients with knee osteoarthritis.
Detailed Description
Metformin is a safe, well-tolerated oral biguanide widely used as first-line therapy for type 2 diabetes for over 50 years. In addition to its glucose-lowering effects, metformin modulates inflammatory and metabolic factors resulting in weight loss and reduced inflammation and plasma lipids. Data from animal studies suggest that metformin could limit OA development and progression, possibly through activating AMPK. Retrospective cohort study of participants with OA and type 2 diabetes reported that patients receiving a combination of cyclooxygenase-2 inhibitors and metformin therapy had a lower risk of joint replacement than those receiving cyclooxygenase-2 inhibitors alone . These findings shed light on possible therapeutic potential of metformin in treatment of OA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Metformin, knee osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo group
Arm Type
Experimental
Arm Description
Placebo tablet twice daily + celecoxib 200mg capsule once daily for 12 weeks.
Arm Title
Metformin group
Arm Type
Experimental
Arm Description
Metformin 500mg tablet twice daily + celecoxib 200mg capsule once daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo Tablet
Intervention Description
Placebo (tablet/12hr) + celecoxib (200mg/day) for three months.
Intervention Type
Drug
Intervention Name(s)
Metformin Hcl 500Mg Tab
Other Intervention Name(s)
Cidophage 500mg Oral Tablet
Intervention Description
Metformin (500mg/12hr) + celecoxib (200mg/day) for three months.
Primary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Description
Measure change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) at baseline and after 12weeks of treatment.
Time Frame
12 weeks
Title
Weight (Kg)
Description
Measure change in weight in kilograms at baseline and after 12weeks of treatment.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Cartilage Oligomeric Matrix Protein (COMP)
Description
Measure change in Cartilage Oligomeric Matrix Protein (COMP) serum level at baseline and after 12weeks of treatment.
Time Frame
12 weeks
Title
C-terminal crosslinked telopeptide of type I collagen (CTX-1)
Description
Measure change in C-terminal crosslinked telopeptide of type I collagen (CTX-1) serum level at baseline and after 12weeks of treatment.
Time Frame
12 weeks
Title
Interleukin 1-beta (IL-1β)
Description
Measure change in Interleukin 1-beta (IL-1β) serum level at baseline and after 12weeks of treatment.
Time Frame
12 weeks
Title
Adverse drug events
Description
side effects
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sahar M El-Haggar, Professor
Organizational Affiliation
Tanta University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Amal M El-Barbary, Professor
Organizational Affiliation
Tanta University
Official's Role
Study Chair
Facility Information:
Facility Name
Tanta university
City
Tanta
State/Province
Gharbia
ZIP/Postal Code
31527
Country
Egypt

12. IPD Sharing Statement

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Metformin as Adjuvant Therapy in Obese Knee Osteoarthritis Patients

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