Effect of Metformin on Patients With Osteoarthritis

NCT ID: NCT05034029

Last Updated: 2022-01-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 262 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2024-12-31

Brief Summary

This randomized controlled trial aims to investigate if metformin has osteoarthritis protective effects among overweighted knee osteoarthritis patients. The co-primary outcomes are changes in tibiofemoral cartilage volume and Western Ontario and McMaster Universities Arthritis Index (WOMAC) from baseline to month 24. The secondary outcomes are changes in visual analog scale (VAS)-assessed knee pain, tibiofemoral cartilage defect, effusion-synovitis volume, and tibiofemoral bone marrow lesion maximum size from baseline to month 24.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Metformin

Metformin hydrochloride sustained release tablet will administer orally in escalating doses to reduce side-effects and maintain masking: 0.5 g/day for the first two weeks, 1 g/day for the next 2 weeks, and then 2 g/day until the end of the study if tolerated. If the subject cannot tolerate the maximum dose (2 g/day), take their maximum tolerable dose. In case of adverse reaction, the researchers can determine whether the subject needs to reduce or stop the drug based on their discretion.

Group Type: EXPERIMENTAL

Metformin hydrochloride sustained release tablets

Intervention Type: DRUG

Oral

Placebo

Placebo will administer the same as the experimental drug.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Metformin hydrochloride sustained release tablets

Oral

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Meet the American College of Rheumatology (ACR) criteria for symptomatic knee osteoarthritis assessed by a rheumatologist;

2. Age 50 to 75 years;

3. Body mass index ≥ 24 kg/m2;

4. Knee pain ≥ 20 on a 100 mm visual analogue scale (VAS);

5. Able to listen, speak, read and understand Chinese; capable of understanding the study requirements and willing to cooperate with the study instructions; able to provide written, informed consent.

Exclusion Criteria

1. Severe radiographic knee OA as grade 3 joint space narrowing according to the Osteoarthritis Research Society International (OARSI) atlas;

2. Severe knee pain as knee pain ≥ 80 on a 100 mm VAS;

3. Planned knee or hip surgery (including arthroscopy, joint replacement, and joint open operation) within 2 years;

4. Severe knee trauma history (including arthroscopy, severe injury of knee ligament or meniscus);

5. Contraindication to MRI scanning (e.g. implanted pacemaker, artificial metal valve or cornea, aneurysm clipping surgery, arterial dissection, metal foreign bodies in the eyeball, claustrophobia);

6. Other forms of inflammatory arthritis (e.g. rheumatoid arthritis, psoriatic arthritis);

7. Active malignant cancer or other life-threatening diseases;

8. Type 1 or type 2 diabetes mellitus;

9. Clinical manifestation of liver dysfunction or alanine aminotransferase/aspartate aminotransferase exceeding 2 times the upper limit of normal value;

10. Estimated glomerular filtration rate less than 60 ml/min/1.73 m2;

11. Hypoxic state (e.g. chronic heart insufficiency, acute myocardial infarction, heart failure, chronic obstructive pulmonary disease, cor pulmonale, peripheral vascular disease);

12. Alcoholism;

13. Pregnancy or lactation;

14. Allergic to metformin hydrochloride;

15. Conditions affecting the absorption of oral drugs (e.g. postgastrectomy and malabsorption syndrome);

16. Use of metformin in recent 30 days or plan to use metformin in the next 2 years;

17. Use of investigational drug in recent 30 days.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou First People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Foshan First People's Hospital

Foshan, Guangzhou, China

Site Status: NOT_YET_RECRUITING

Guangzhou First People's Hospital

Guangzhou, , China

Site Status: RECRUITING

Liwan Central Hospital of Guangzhou

Guangzhou, , China

Site Status: NOT_YET_RECRUITING

Sun Yat-Sen Memorial Hospital

Guangzhou, , China

Site Status: NOT_YET_RECRUITING

Zhujiang Hospital

Guangzhou, , China

Site Status: NOT_YET_RECRUITING

Countries

China

Central Contacts

Guangfeng Ruan, Doctor

Role: CONTACT

ruan1989.ok@163.com

13060627790 ext. +86

Facility Contacts

Dongmei Guo, Master

Role: primary

Guangfeng Ruan, Doctor

Role: primary

ruan1989.ok@163.com

13060627790 ext. +86

Aiju Lou, Doctor

Role: primary

Yingqian Mo, Doctor

Role: primary

Yuan Qu, Doctor

Role: primary

References

Ruan G, Yuan S, Lou A, Mo Y, Qu Y, Guo D, Guan S, Zhang Y, Lan X, Luo J, Mei Y, Zhang H, Wu W, Dai L, Yu Q, Cai X, Ding C. Can metformin relieve tibiofemoral cartilage volume loss and knee symptoms in overweight knee osteoarthritis patients? Study protocol for a randomized, double-blind, and placebo-controlled trial. BMC Musculoskelet Disord. 2022 May 21;23(1):486. doi: 10.1186/s12891-022-05434-2.

Reference Type: DERIVED

PMID: 35598008 (View on PubMed)

Other Identifiers

K-2021-001-02

Identifier Type: -

Identifier Source: org_study_id