Understanding diabetes risk in patients with giant cell arthritis and polymyalgia rheumatica
Risk of Diabetes Mellitus in Patients With Giant Cell Arthritis and Polymyalgia Rheumatica.
This study is trying to see if patients with giant cell arthritis and polymyalgia rheumatica who are treated with certain medications are at higher risk of developing diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | Aalborg University Hospital Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Aalborg, Nordjylland) |
| Trial ID | NCT06011512 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the risk of developing diabetes mellitus in patients diagnosed with giant cell arthritis (GCA) and polymyalgia rheumatica (PMR), particularly those treated with glucocorticoids and interleukin-6 inhibitors. Participants will be followed at rheumatology clinics, providing blood samples and clinical data at regular intervals to identify potential comorbidities and clinical outcomes. The study will utilize machine learning to analyze biomarkers and predict the development or worsening of diabetes in these patients.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 50 to 85 years diagnosed with GCA or PMR.
Not a fit: Patients outside the age range of 50 to 85 years or those not diagnosed with GCA or PMR may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better management strategies for diabetes risk in patients with GCA and PMR.
How similar studies have performed: While the specific approach of this study is novel, previous studies have explored diabetes risk in similar patient populations, indicating potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men or women aged 50 to 85 years * Are diagnosed with GCA or PMR * Diagnosis is established by or confirmed by a rheumatologist (clinical expert opinion) * Speak and understand Danish * Are able to give signed and dated informed consent Exclusion Criteria: * None
Where this trial is running
Aalborg, Nordjylland
- Aalborg University Hospital — Aalborg, Nordjylland, Denmark (Recruiting)
Study contacts
- Principal investigator: Salome Kristensen, MD, PhD — Aalborg University Hospital
- Study coordinator: Mads ER Sørensen, M.Sc.
- Email: m.engell@rn.dk
- Phone: 97 66 69 99
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.