Effect of Metformin on Carotid Atherosclerosis for Non-diabetic Patients With PsA (CAMPA Study)
Study Purpose
Background: Psoriatic arthritis (PsA) is a common chronic inflammatory disease with a prevalence up to 670 every 100,000 subjects. Patients with PsA has an increased risk of cardiovascular disease (CVD) which is one of the major causes of death. The investigators hypothesize that metformin in combination of a treat-to-target (T2T) strategy aiming at tight disease control is more effective in preventing progression of subclinical arthrosclerosis than T2T strategy alone in non-diabetic PsA patients. Objective: To investigate the vascular effects of metformin in PsA patients without diabetes mellitus. The metabolic and anti-inflammatory roles of metformin will also be explored. Study design: This is a 1-year, single-centered, pilot, open-labelled, randomized controlled trial. A total of 24 enrolled patients with PsA being followed at the Prince of Wales Hospital rheumatology clinics will be recruited and randomized to either metformin group or control group in a 1:1 ratio. Participants randomized to the metformin group will be instructed to take 500 mg metformin daily for 1 week before titrating up to twice a day (one with the morning meal, one with the evening meal) to reduce gastro-intestinal adverse events. Expected outcomes: The data from this study will support that there will be significant difference in the proportion of subjects with carotid plaque progression between the metformin group and control group over a period of 1 year.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05988684 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 4 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Chinese University of Hong Kong |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
Principal Investigator Affiliation | N/A |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
Overall Status | Recruiting |
Countries | Hong Kong |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
PsA (Psoriatic Arthritis) |
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.