Using Metformin to Improve Heart Health in Non-Diabetic PsA Patients

Effect of Metformin on Carotid Atherosclerosis for Non-diabetic Patients With Psoriatic Arthritis - a Pilot Randomized Controlled Trial

This study is testing if the diabetes drug metformin can help improve heart health in people with psoriatic arthritis who don't have diabetes.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Chinese University of Hong Kong (other)
• Drugs / interventions: methotrexate
• Locations: 1 site (Hong Kong)
• Trial ID: NCT05988684 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of metformin on carotid atherosclerosis in non-diabetic patients with psoriatic arthritis (PsA). It aims to determine whether metformin, combined with a treat-to-target strategy for disease control, is more effective than the strategy alone in preventing the progression of subclinical atherosclerosis. The study will enroll 24 participants who will be randomized into two groups: one receiving metformin and the other serving as a control. Participants will be monitored over a year, with treatment adjustments made based on their response to therapy.

Who should consider this trial

Good fit: Ideal candidates are non-diabetic adults over 18 with psoriatic arthritis and a moderate to high cardiovascular risk.

Not a fit: Patients with pre-existing diabetes or significant liver or renal impairment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new approach to reducing cardiovascular risks in patients with psoriatic arthritis.

How similar studies have performed: While the use of metformin in diabetic patients is well-established, this approach in non-diabetic PsA patients is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. fulfill the ClASsification criteria for Psoriatic ARthritis (CASPAR),
2. are over 18 years old,
3. have a Framingham Risk Score ≥ 10% (i.e. moderate to high CV risk) and
4. have carotid plague on previous ultrasound.

Exclusion Criteria:

1. have prior therapy with metformin during the last 6 months;
2. have pre-existing diabetes as defined by the World Health Organization (WHO) criteria:

   * fasting plasma glucose values of ≥ 7.0 mmol/L,
   * 2-h post-load plasma glucose ≥ 11.1 mmol/L,
   * HbA1c ≥ 6.5% or
   * a random blood glucose ≥ 11.1 mmol/L);
3. have liver impairment: ALT more than or equal to 2.5×upper limits of normal;
4. have renal impairment: serum creatinine levels more than or equal to 135µmol/L in males and more than or equal to 110µmol/L in females;
5. have had ACS within the previous 3 months;
6. have New York Heart Association functional class 3 or 4 heart failure;
7. have uncontrolled angina;
8. have 70% or more stenosis on initial CCTA;
9. have clinically relevant current malignancy;
10. are pregnant; breastfeeding or of childbearing potential but unwilling to use adequate contraception;
11. are unable to give written informed consent;
12. patients with moderate to heavy alcohol intake.

Where this trial is running

Hong Kong

• The Chinese University of Hong Kong — Hong Kong, Hong Kong (RECRUITING)

Study contacts

• Study coordinator: ho SO

Conditions: PsA