Risk of Diabetes Mellitus in Patients With Giant Cell Arthritis and Polymyalgia Rheumatica.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Proportion of participants developing diabetes mellitus during the study period, measured in changes of HbA1c.
研究概览
简要总结
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.
详细描述
The cohort study is a prospective national cohort study in patients with giant cell arthritis (GCA) and polymyalgia rheumatica (PMR). At baseline and follow-up visits at month 1, 3, 6, 12, and every year while patients are treated at departments of rheumatology, collection of demographics, clinical data, patient reported outcomes and blood samples (Regionernes blod- og GenomBank) will occur.
Trial procedure:
Diagnostic information and referral history:
At enrollment, patients will be registered as either incident (first visit within 3 months from diagnosis) or prevalent. The patients diagnosis, time of diagnosis, type of physician establishing diagnosis, time of symptom onset, time of referral, time of first visit, date of prednisolone start, initial prednisolone dose, basis for diagnosis (clinical, classification criteria, biochemical, ultrasound, PET/CT, other imaging modalities, temporal artery biopsy), fulfillment of 1990 ACR classification criteria for GCA, fulfillment of 2018 DCVAS classification criteria for GCA, fulfillment of 2012 EULAR PMR classification criteria will be recorded. Disease stratification will be performed according to clinical diagnosis and imaging test results available. Accordingly, patients will be categorized as either 'GCA', 'PMR', 'GCA and PMR'. If a GCA diagnosis is established, patients will be further categorized as 'c-GCA', 'LV-GCA'
Clinical evaluation:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Proportion of participants developing diabetes mellitus during the study period, measured in changes of HbA1c.
时间窗: At baseline, and month 1, 3, 6, 12, 24 and 36.
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.
次要结局
- Changes in homeostatic model assessment for insulin resistance.(At baseline, and month 1, 3, 6, 12, 24 and 36.)
- Changes in fasting blood glucose.(At baseline, and month 1, 3, 6, 12, 24 and 36.)
- Duration and cumulative glucocorticoid dosage(At baseline, and month 1, 3, 6, 12, 24 and 36.)
- Changes in proinsulin C-peptide.(At baseline, and month 1, 3, 6, 12, 24 and 36.)
- Changes in patient pain numerical rating scale headache (0-10).(At baseline, and month 12, 24, 36, 48, and 60.)
- Changes in morning stiffness numerical rating scale (0-10).(At baseline, and month 12, 24, 36, 48, and 60.)
- Changes in European Quality of life-5dimension5-levels(At baseline, and month 12, 24, 36, 48, and 60.)
- Changes in fasting proinsulin C-peptide.(At baseline, and month 1, 3, 6, 12, 24 and 36.)
- Changes in patient pain numerical rating scale, neck, shoulder, pelvic, thigh (0-10).(At baseline, and month 12, 24, 36, 48, and 60.)
- Changes in CRP.(At baseline, and month 1, 3, 6, 12, 24 and 36.)
- Changes in duration of morning stiffness.(At baseline, and month 12, 24, 36, 48, and 60.)
- Changes in CD36.(At baseline, and month 1, 3, 6, 12, 24 and 36.)
- Changes in sCD36.(At baseline, and month 1, 3, 6, 12, 24 and 36.)
研究者
Salome Kristensen
MD, PhD
Aalborg University Hospital