Giant Cell Arteritis Clinical Trial
Official title:
Risk of Diabetes Mellitus in Patients With Giant Cell Arthritis and Polymyalgia Rheumatica.
NCT number | NCT06011512 |
Other study ID # | AalborgGCA |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 1, 2023 |
Est. completion date | June 1, 2026 |
The goal of this observational study is to expand the knowledge about development and aggreviation of diabetes mellitus in patients with giant cell arthritis and polymyalgia rheumatica. The main questions it aims to answer are: - To identify the risk of comorbidities, especially diabetes, in patients with giant cell arthritis and polymyalgia rheumatica, treated with glucocorticoids in combination with or without interleukin-6 inhibitor. - To identify clinical outcomes and biomarkers as potential predictors for development or aggregation of already existing diabetes mellitus in patients with giant cell arthritis or polymyalgia rheumatica using machine learning prediction. Participants will be followed at their respective rheumatology clinic, and will be asked to deliver blood samples at predefined visits.
Status | Recruiting |
Enrollment | 800 |
Est. completion date | June 1, 2026 |
Est. primary completion date | June 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Aalborg University Hospital | Aalborg | Nordjylland |
Lead Sponsor | Collaborator |
---|---|
Salome Kristensen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of participants developing diabetes mellitus during the study period, measured in changes of HbA1c. | HbA1c is glycated hemoglobin, which means that hemoglobin is chemically bound to glucose in the bloodstream. HbA1c is a relative measure of the average glucose in the bloodstream during the past 3 months, and is used to diagnose patients with diabetes mellitus. | At baseline, and month 1, 3, 6, 12, 24 and 36. | |
Secondary | Changes in CD36. | CD36 is a protein that helps importing fatty acids inside the cell. | At baseline, and month 1, 3, 6, 12, 24 and 36. | |
Secondary | Changes in sCD36. | CD36 is a protein that helps importing fatty acids inside the cell. | At baseline, and month 1, 3, 6, 12, 24 and 36. | |
Secondary | Changes in homeostatic model assessment for insulin resistance. | Homeostatic model assessment for insulin resistance (HOMA-IR) is a score that approximates insulin resistance. | At baseline, and month 1, 3, 6, 12, 24 and 36. | |
Secondary | Changes in proinsulin C-peptide. | Proinsulin C-peptide is a marker for the insulinproduction. | At baseline, and month 1, 3, 6, 12, 24 and 36. | |
Secondary | Changes in fasting proinsulin C-peptide. | Proinsulin C-peptide is a marker for the insulinproduction. | At baseline, and month 1, 3, 6, 12, 24 and 36. | |
Secondary | Changes in fasting blood glucose. | Blood glucose is the amount of glucose in the bloodstream. | At baseline, and month 1, 3, 6, 12, 24 and 36. | |
Secondary | Changes in CRP. | CRP is a pro-inflammatory marker. | At baseline, and month 1, 3, 6, 12, 24 and 36. | |
Secondary | Changes in patient pain numerical rating scale, neck, shoulder, pelvic, thigh (0-10). | Patient pain numerical rating scale, neck, shoulder, pelvic, thigh is a rating scale in which patients are asked to rate the pain from 0 to 10 in the chosen areas, with 0 being "no pain" and 10 being "worst pain imaginable". | At baseline, and month 12, 24, 36, 48, and 60. | |
Secondary | Changes in patient pain numerical rating scale headache (0-10). | Patient pain numerical rating scale headache is a rating scale in which patients are asked to rate their headache pain from 0 to 10 with 0 being "no pain" and 10 being "worst pain imaginable". | At baseline, and month 12, 24, 36, 48, and 60. | |
Secondary | Changes in duration of morning stiffness. | With regard to duration of morning stiffness, patients are asked to rate the duration of their morning stiffness with 0 being no stiffness and 10 being 2 hours of stiffness or more. | At baseline, and month 12, 24, 36, 48, and 60. | |
Secondary | Changes in morning stiffness numerical rating scale (0-10). | Moring stiffness numerical rating scale is a measure of the difficulty the morning stiffness are causing, with 0 being "no difficulty" and 10 being "the worst imaginable difficulty". | At baseline, and month 12, 24, 36, 48, and 60. | |
Secondary | Changes in European Quality of life-5dimension5-levels | European Quality of life-5dimension5-levels is descriptive system that measures patients health related quality of life. This system consists of 5 dimensions: Mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension consists of 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. | At baseline, and month 12, 24, 36, 48, and 60. | |
Secondary | Duration and cumulative glucocorticoid dosage | It is known that treatment with glucocorticoid dosage in patients with inflammatory diseases is the number one reason for drug-induced hyperglycaemia and DM, and that GC can aggreviate hyperglycaemia in patients with a prior diagnosis of DM. | At baseline, and month 1, 3, 6, 12, 24 and 36. |
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